PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Melli… (NCT00690066) | Clinical Trial Compass
CompletedPhase 2
PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
United States63 participantsStarted 2008-06-11
Plain-language summary
The purpose of this study is to establish the safety and efficacy of multiple administrations of PROCHYMAL® in participants recently diagnosed with type 1 diabetes mellitus.
Who can participate
Age range12 Years – 35 Years
SexALL
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Inclusion Criteria:
* Participant must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) criteria.
* Participant must be screened between 2 and 20 weeks from initial T1DM diagnosis
* Participants must be between the ages of 12 and 35 (inclusive).
* Participant must have at least one diabetes-related autoantibody present (either GAD or IA-2).
* Participant must have some beta cell function as determined by C-peptide testing (at least 0.2 pmol/mL (0.6 ng/mL) during MMTT.
* Participants must be willing to comply with "intensive diabetes management" as directed by the Investigator with the goal of maintaining blood glucose as close to normal as possible (i.e., glycosylated hemoglobin A1c (HbA1c) value of ≤ 7.0%).
* Participants must be willing to comply with the schedule of study visits and protocol requirements.
Exclusion Criteria:
* Participant has Body Mass Index (BMI) ≥ 30.
* Participant has evidence of retinopathy at baseline.
* Participant has abnormally high lipid levels.
* Participant has abnormal blood pressure.
* Participant has an abnormal serum creatinine.
* Participant has evidence of clinically significant proteinuria.
* Participant has diabetic ketoacidosis.
* Participant is being treated for a severe active infection of any type.
* A female participant who is breast-feeding, pregnant, or intends to become pregnant during the study.
* Participant with clinically relevant uncontrolled medical condition not associated wi…
What they're measuring
1
C-peptide area under the concentration curve (AUC) response (MMTT)