Trial Outcomes & Findings for Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus (NCT NCT00315614)

Last Updated: 2017-04-04

Results Overview

Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

for the duration of islet graft function

Results posted on

2017-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Islet Transplantation and Bone Marrow Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Islet Transplantation and CD34 Bone Marrow n=3 Participants Islet Transplantation: Islet transplantation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: for the duration of islet graft function

Population: IImmunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint. No data available to analyze.

Outcome measures

Outcome measures
Measure	Islet Transplantation and CD34 Bone Marrow Islet Transplantation: Islet transplantation
The Achievement of Persistent Islet Function Following Cessation of Immunosuppression.	0

PRIMARY outcome

Timeframe: for the duration of islet graft function

Number of rejection episodes after transplantation. Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: for the duration of islet graft function

Number of subjects with basal C-peptide greater than 0.5 ng/ml prior to weaning of immunosuppression;

Outcome measures

Outcome measures
Measure	Islet Transplantation and CD34 Bone Marrow n=3 Participants Islet Transplantation: Islet transplantation
Number of Subjects With Basal C-peptide Greater Than 0.5 ng/ml	3 Participants

SECONDARY outcome

Timeframe: for the duration of islet graft function

Number of subjects with reduction of episodes of severe hypoglycemia and the presence of awareness of hypoglycemia

Outcome measures

Outcome measures
Measure	Islet Transplantation and CD34 Bone Marrow n=3 Participants Islet Transplantation: Islet transplantation
Number of Subjects With Reduction of Severe Hypoglycemia and Improvement in Hypoglycemia Awareness	3 Participants

Adverse Events

Islet Transplantation and CD34 Bone Marrow

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Islet Transplantation and CD34 Bone Marrow n=3 participants at risk Islet Transplantation: Islet transplantation
Cardiac disorders Syncope leading to fracture of Humerus	33.3% 1/3 • Number of events 1
Endocrine disorders Severe hypoglycemia	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3 • Number of events 1

Other adverse events

Other adverse events
Measure	Islet Transplantation and CD34 Bone Marrow n=3 participants at risk Islet Transplantation: Islet transplantation
Nervous system disorders Anxiety	33.3% 1/3 • Number of events 1
Nervous system disorders Tremors	33.3% 1/3 • Number of events 2
Nervous system disorders Insomina	33.3% 1/3 • Number of events 1
Nervous system disorders Headache	33.3% 1/3 • Number of events 2
Eye disorders Retinal Hemorrhage	33.3% 1/3 • Number of events 1
Skin and subcutaneous tissue disorders Pruritic Rash	33.3% 1/3 • Number of events 1
Skin and subcutaneous tissue disorders Facial Rash	33.3% 1/3 • Number of events 1
Skin and subcutaneous tissue disorders Onychomycosis	33.3% 1/3 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus in perianal area	33.3% 1/3 • Number of events 1
Skin and subcutaneous tissue disorders Neck rash non-pruritic	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders Neutropenia	66.7% 2/3 • Number of events 3
Blood and lymphatic system disorders Lymphopenia	66.7% 2/3 • Number of events 2
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1
Musculoskeletal and connective tissue disorders Calf pain	33.3% 1/3 • Number of events 1
Musculoskeletal and connective tissue disorders Left arm pain	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 2
Gastrointestinal disorders Oral ulcers	66.7% 2/3 • Number of events 3
Gastrointestinal disorders Nausea and vomiting	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Explosive Diarrhea	33.3% 1/3 • Number of events 1
Hepatobiliary disorders Gallbladder Thickening	33.3% 1/3 • Number of events 1
Cardiac disorders Palpitations	33.3% 1/3 • Number of events 2
Blood and lymphatic system disorders Pretibial and ankle edema	33.3% 1/3 • Number of events 1
Cardiac disorders Hypertension	33.3% 1/3 • Number of events 2
Cardiac disorders Vasovagal reaction during procedure	33.3% 1/3 • Number of events 1
General disorders Fatigue	33.3% 1/3 • Number of events 1
Endocrine disorders Severe Hypoglycemia	33.3% 1/3 • Number of events 1
Metabolism and nutrition disorders High CPK	33.3% 1/3 • Number of events 2
Metabolism and nutrition disorders Elevated LFT	66.7% 2/3 • Number of events 3
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 1
Infections and infestations HPV infection	33.3% 1/3 • Number of events 1
Reproductive system and breast disorders Cervical intraepithelial neoplasia	33.3% 1/3 • Number of events 1
Reproductive system and breast disorders Cervical Polyp	33.3% 1/3 • Number of events 1
Infections and infestations Pharyngitis and Bronchitis	33.3% 1/3 • Number of events 1
Infections and infestations Urinary Tract Infection	66.7% 2/3 • Number of events 3
Infections and infestations Upper respiratory infection	33.3% 1/3 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural Effusion	33.3% 1/3 • Number of events 1
Respiratory, thoracic and mediastinal disorders Upper respiratory Congestion	33.3% 1/3 • Number of events 1
Infections and infestations Candidiasis	33.3% 1/3 • Number of events 1
Infections and infestations Ringworm infection	33.3% 1/3 • Number of events 2

Additional Information

Dr. Rodolfo Alejandro

University of Miami

Phone: 3052435324

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place