Trial Outcomes & Findings for Phase I/II Thymus Transplantation With Immunosuppression #950 (NCT NCT00579527)
NCT ID: NCT00579527
Last Updated: 2022-03-25
Results Overview
Survival at 1 year post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
1 year post-CTTI
Results posted on
2022-03-25
Participant Flow
The goal of this study is survival of subjects after cultured thymus tissue implantation (CTTI) regardless of the immunosuppressive regimen or of parathyroid co-transplantation.
Participant milestones
| Measure |
Cultured Thymus Tissue Implantation w/ Immunosuppression
Participants enrolled in cultured thymus tissue implantation (CTTI) with immunosuppression were given immunosuppression based on results of flow cytometry without consideration of whether a parathyroid transplant would be given.
No participants were enrolled into Arm 2. No subjects received a parathyroid transplant.
No specific dose of cultured thymus tissue was assigned. The dose was the number of grams of cultured thymus tissue divided by the weight of the recipient in kg or per square meter of body surface area of the participant.
There was one administration of cultured thymus tissue. The dosage form was cultured thymus tissue.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Cultured Thymus Tissue Implantation w/ Immunosuppression
Participants enrolled in cultured thymus tissue implantation (CTTI) with immunosuppression were given immunosuppression based on results of flow cytometry without consideration of whether a parathyroid transplant would be given.
No participants were enrolled into Arm 2. No subjects received a parathyroid transplant.
No specific dose of cultured thymus tissue was assigned. The dose was the number of grams of cultured thymus tissue divided by the weight of the recipient in kg or per square meter of body surface area of the participant.
There was one administration of cultured thymus tissue. The dosage form was cultured thymus tissue.
|
|---|---|
|
Overall Study
Death
|
4
|
Baseline Characteristics
Phase I/II Thymus Transplantation With Immunosuppression #950
Baseline characteristics by cohort
| Measure |
Cultured Thymus Tissue Implantation With Immunosuppression
n=14 Participants
Participants enrolled into cultured thymus tissue for implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell number and function.
|
|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
248 days
STANDARD_DEVIATION 161 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race (Caucasian/Asian)
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post-CTTIPopulation: The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
Survival at 1 year post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=14 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Survival at 1 Year Post-CTTI
|
71 % of participants who survive to 1 year
Interval 40.6 to 88.2
|
SECONDARY outcome
Timeframe: 2 years post-CTTIPopulation: The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
Survival at 2 years post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=14 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Survival at 2 Years Post-CTTI
|
71 % of participants who survive to 2 years
Interval 40.6 to 88.2
|
SECONDARY outcome
Timeframe: 1 year post-CTTIPopulation: Data were only included for the 1 year time point if a CD3 T cell count was performed in relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
The development of total CD3 T cells at one year as measured using flow cytometry
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=9 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Immune Reconstitution Efficacy - Total CD3 T Cells
|
726 cells/mm3
Interval 345.0 to 1866.0
|
SECONDARY outcome
Timeframe: 1 year post-CTTIPopulation: Data were only included for the 1 year time point if a CD4 T cell count was performed in relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
The development of total CD4 T cells at one year as measured using flow cytometry
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=10 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Immune Reconstitution Efficacy - Total CD4 T Cells
|
593 cells/mm3
Interval 230.0 to 1780.0
|
SECONDARY outcome
Timeframe: 1 year post-CTTIPopulation: Data were only included for the 1 year time point if a CD8 T cell count was performed in relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
The development of total CD8 T cells at one year as measured using flow cytometry
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=10 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Immune Reconstitution Efficacy - Total CD8 T Cells
|
145 cells/mm3
Interval 22.0 to 360.0
|
SECONDARY outcome
Timeframe: 1 year post-CTTIPopulation: Data were only included for the 1 year time point if a T cell count was performed in relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
The development of total naive CD4 T cells at one year as measured using flow cytometry
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=9 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Immune Reconstitution Efficacy - Naive CD4 T Cells
|
156 cells/mm3
Interval 23.0 to 751.0
|
SECONDARY outcome
Timeframe: 1 year post-CTTIPopulation: Data were only included for the 1 year time point if a T cell count was performed in the relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
The development of total naive CD8 T cells at one year as measured using flow cytometry
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=9 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Immune Reconstitution Efficacy - Naive CD8 T Cells
|
37 cells/mm3
Interval 4.0 to 217.0
|
SECONDARY outcome
Timeframe: 1 year post-CTTIPopulation: Data were only included for the 1 year time point if a testing was performed in the relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
Measurement of the T cell proliferative response to the mitogen phytohemagglutin (PHA).
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=8 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Immune Reconstitution Efficacy - Response to Mitogens
|
139189 counts per minute (cpm)
Interval 13726.0 to 202132.0
|
SECONDARY outcome
Timeframe: 2 to 3 months post-CTTIPopulation: Data were only included if the participant had a biopsy of the thymus tissue implanted. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.
Evidence, on biopsy of the thymus tissue implanted in muscle, that shows the development of new T cells.
Outcome measures
| Measure |
Cultured Thymus Tissue With Immunosuppression
n=10 Participants
Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
|
|---|---|
|
Thymus Allograft Biopsy
Evidence of thymopoiesis
|
7 Participants
|
|
Thymus Allograft Biopsy
Evidence of rejection
|
0 Participants
|
|
Thymus Allograft Biopsy
Inconclusive for thymopoiesis
|
3 Participants
|
Adverse Events
Cultured Thymus Tissue Implantation With Immunosuppression
Serious events: 13 serious events
Other events: 14 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cultured Thymus Tissue Implantation With Immunosuppression
n=14 participants at risk
Participants enrolled into Cultured Thymus Tissue Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events were combined for this analysis regardless of the immunosuppression used.
|
|---|---|
|
Infections and infestations
Device related infection
|
78.6%
11/14 • Number of events 34 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
General disorders
Pyrexia
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Immune system disorders
Cytokine release syndrome
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
14.3%
2/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Cytomegalovirus infection
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.1%
1/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Nervous system disorders
Hypocalcaemic seizure
|
7.1%
1/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Blood and lymphatic system disorders
Haemolysis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Enteritis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Pancreatitis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Immune system disorders
Hypersensitivity
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Immune system disorders
Systemic immune activation
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Cystitis escherichia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Cystitis klebsiella
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Enterobacter bacteraemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Enterococcal bacteraemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Pneumonia haemophilus
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Pneumonia moraxella
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Respiratory tract infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Staphylococcal skin infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Injury, poisoning and procedural complications
Wound complication
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Blood bicarbonate decreased
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Nervous system disorders
Cerebral atrophy
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Renal and urinary disorders
Renal failure
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Granuloma skin
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Vascular disorders
Thrombosis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
Other adverse events
| Measure |
Cultured Thymus Tissue Implantation With Immunosuppression
n=14 participants at risk
Participants enrolled into Cultured Thymus Tissue Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events were combined for this analysis regardless of the immunosuppression used.
|
|---|---|
|
Vascular disorders
Hypertension
|
71.4%
10/14 • Number of events 11 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
42.9%
6/14 • Number of events 6 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Immune system disorders
Cytokine release syndrome
|
35.7%
5/14 • Number of events 6 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Endocrine disorders
Hypothyroidism
|
28.6%
4/14 • Number of events 4 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Urinary tract infection bacterial
|
28.6%
4/14 • Number of events 6 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
4/14 • Number of events 5 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
General disorders
Pyrexia
|
28.6%
4/14 • Number of events 5 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
4/14 • Number of events 5 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
28.6%
4/14 • Number of events 5 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
4/14 • Number of events 5 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Cardiac disorders
Sinus bradycardia
|
21.4%
3/14 • Number of events 4 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Occult blood positive
|
21.4%
3/14 • Number of events 4 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Cardiac disorders
Sinus tachycardia
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Constipation
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Clostridium difficile colitis
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Ear infection
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Fungal skin infection
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Eye infection bacterial
|
14.3%
2/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
2/14 • Number of events 3 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Ileus
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Rhinitis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Injury, poisoning and procedural complications
Stoma site hypergranulation
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Blood bicarbonate decreased
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Blood chloride decreased
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Blood creatinine increased
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Blood urea increased
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Nervous system disorders
Seizure
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
14.3%
2/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Immune system disorders
Hypersensitivity
|
7.1%
1/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Oral candidiasis
|
7.1%
1/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
7.1%
1/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
7.1%
1/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
7.1%
1/14 • Number of events 2 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Haematochezia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Rectal prolapse
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
General disorders
Injection site reaction
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Hepatobiliary disorders
Cholestasis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Hepatobiliary disorders
Hepatomegaly
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Cystitis klebsiella
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Eye infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Otitis media
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Otitis media acute
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Pneumonia moraxella
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Staphylococcal skin infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Stoma site infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Viral diarrhoea
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Infections and infestations
Wound infection staphylococcal
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Blood immunoglobulin E increased
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Blood triglycerides increased
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Protein total decreased
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Red blood cell morphology abnormal
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Investigations
Weight decreased
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Disaccharidase deficiency
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Fluid retention
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Nervous system disorders
Hypotonia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Renal and urinary disorders
Nephrocalcinosis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Renal and urinary disorders
Renal failure
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Reproductive system and breast disorders
Bilateral breast buds
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Vascular disorders
Lymphorrhoea
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
|
Vascular disorders
Thrombosis
|
7.1%
1/14 • Number of events 1 • 2 years post-CTTI
Participants enrolled into Cultured Thymus Tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events are reported below.
|
Additional Information
M. Louise Markert, MD, PhD Professor of Pediatrics and Immunology
Duke University Medical Center
Phone: 919-684-6263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place