Trial Outcomes & Findings for Umbilical Cord Blood Infusion to Treat Type 1 Diabetes (NCT NCT00305344)

Results Overview

All participants were monitored for 2 years. Baseline and post-infusion mixed meal tolerance tests were performed to determine whether autologous cord blood infusion preserved endogenous insulin production. The change in median area under the curve for C-peptide (measure of insulin production) from baseline to to 2 years during a 2 hour mixed meal tolerance test was used as the primary outcome measure and was reported in ng/ml/120 minutes

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Baseline to Year 2

Results posted on

2022-02-09

Participant Flow

23 total subjects were enrolled.

Patients with autologous cord blood in private storage facilities were eligible. No eligible patients were excluded.

Participant milestones

Participant milestones
Measure	Cord Blood Recipient Umbilical Cord Recipient
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Umbilical Cord Blood Infusion to Treat Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cord Blood Recipient n=23 Participants Umbilical Cord Recipient
Age, Categorical <=18 years	23 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	5.1 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Year 2

Population: All participants received their own autologous umbilical cord blood (UCB)

All participants were monitored for 2 years. Baseline and post-infusion mixed meal tolerance tests were performed to determine whether autologous cord blood infusion preserved endogenous insulin production. The change in median area under the curve for C-peptide (measure of insulin production) from baseline to to 2 years during a 2 hour mixed meal tolerance test was used as the primary outcome measure and was reported in ng/ml/120 minutes

Outcome measures

Outcome measures
Measure	Recipients Receiving Cord Blood n=23 Participants Children with type 1 diabetes who underwent an autologous cord blood infusion
Children With T1D Underwent a Single Autologous UCB Transfusion	-0.6 ng /ml /120 min Interval -1.0 to -0.37

Adverse Events

Cord Blood Recipients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Michael Haller

University of Florida

Phone: 352.273.9264

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place