Trial Outcomes & Findings for A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease (NCT NCT03270956)
NCT ID: NCT03270956
Last Updated: 2025-03-24
Results Overview
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Through 24 months following last REACT injection
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
Renal Autologous Cell Therapy (REACT)
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Renal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)
|
|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Renal Autologous Cell Therapy (REACT)
n=10 Participants
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Renal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)
|
|---|---|
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Age, Continuous
|
58.3 years
STANDARD_DEVIATION 5.03 • n=5 Participants
|
|
Sex: Female, Male
Female
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5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
BMI (kg/m^2) at Screening,
|
35.20 kg/m^2
STANDARD_DEVIATION 8.415 • n=5 Participants
|
|
Volume (cm^3) - Treated kidney
|
180.97 cm^3
STANDARD_DEVIATION 76.077 • n=5 Participants
|
|
Volume (cm^3) - Untreated kidney
|
163.93 cm^3
STANDARD_DEVIATION 35.279 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through 24 months following last REACT injectionPercentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
Outcome measures
| Measure |
Renal Autologous Cell Therapy (REACT)
n=10 Participants
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Renal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)
|
|---|---|
|
Procedure and/or Product Related Adverse Events
All Body Systems
|
70.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
Renal and urinary disorders
|
60.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
renal haematoma
|
30.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
subcapsular renal hematoma
|
20.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
haematuria
|
10.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
perinephric collection
|
10.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
Blood and lymphatic system disorder
|
10.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
anaemia
|
10.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
General disorders and administration site conditions
|
10.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
fatigue
|
10.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
Injury, poisoning, and procedural complications
|
10.0 percent of participants
|
|
Procedure and/or Product Related Adverse Events
procedural pain
|
10.0 percent of participants
|
SECONDARY outcome
Timeframe: Through 24 months following last REACT injectionPercentage of subjects with renal-specific adverse events by System Order Class and Preferred Term
Outcome measures
| Measure |
Renal Autologous Cell Therapy (REACT)
n=10 Participants
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Renal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)
|
|---|---|
|
Renal Specific Adverse Events
Renal and urinary disorders
|
90.0 percent of participants
|
|
Renal Specific Adverse Events
End Stage Renal Disease
|
50.0 percent of participants
|
|
Renal Specific Adverse Events
Renal haematoma
|
40.0 percent of participants
|
|
Renal Specific Adverse Events
Acute Kidney Disease
|
30.0 percent of participants
|
|
Renal Specific Adverse Events
Chronic Kidney Disease
|
20.0 percent of participants
|
|
Renal Specific Adverse Events
Subcapsular renal haematoma
|
20.0 percent of participants
|
|
Renal Specific Adverse Events
Haematuria
|
10.0 percent of participants
|
|
Renal Specific Adverse Events
Hydronephrosis
|
10.0 percent of participants
|
|
Renal Specific Adverse Events
perinephric collection
|
10.0 percent of participants
|
Adverse Events
Renal Autologous Cell Therapy (REACT)
Serious events: 8 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Renal Autologous Cell Therapy (REACT)
n=10 participants at risk
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Renal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)
|
|---|---|
|
Renal and urinary disorders
ESRD
|
40.0%
4/10 • Number of events 4 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
2/10 • Number of events 2 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
20.0%
2/10 • Number of events 2 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Infections and infestations
COVID-19
|
20.0%
2/10 • Number of events 2 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Infections and infestations
Abdominal wall abscess
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Nervous system disorders
Cerebrovascular accident
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Renal and urinary disorders
Chronic kidney disease
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Infections and infestations
COVID-19 pneumonia
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Vascular disorders
Hypertensive emergency
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
10.0%
1/10 • Number of events 1 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
Other adverse events
| Measure |
Renal Autologous Cell Therapy (REACT)
n=10 participants at risk
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Renal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)
|
|---|---|
|
Renal and urinary disorders
ESRD
|
50.0%
5/10 • Number of events 5 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
General disorders
Fatigue
|
40.0%
4/10 • Number of events 5 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Infections and infestations
Urinary tract infection
|
40.0%
4/10 • Number of events 5 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • Number of events 4 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Renal and urinary disorders
renal haematoma
|
40.0%
4/10 • Number of events 4 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Renal and urinary disorders
Acute kidney injury
|
30.0%
3/10 • Number of events 3 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10 • Number of events 3 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Infections and infestations
COVID-19
|
30.0%
3/10 • Number of events 3 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Number of events 3 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
|
General disorders
Pyrexia
|
30.0%
3/10 • Number of events 3 • the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 60-day review period can be extended an additional 30 days if Sponsor determines publication describes potentially patentable inventions. Publication not to be delayed more than 90 days after receipt of the proposed publication. Sponsor may not require changes to the communication except to request removal of Sponsor Confidential Information. No publication or disclosure shall be made by PI until the earlier of publication coordinated by Sponsor or 18 months after Study completion
- Publication restrictions are in place
Restriction type: OTHER