Clinical trialNo phase (not a drug trial)Recruiting
UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes
Investigation of Dose Escalation and Dose Expansion Study on the Safety and Efficacy of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes
- Outcome
- Ongoing
- Phase
- No phase (not a drug trial)
- Status
- Recruiting
- Study type
- Interventional
- Start
- 30 December 2024
- Expected end
- 1 December 2026
- Enrollment
- 16 participants
- Sites
- 1
- Primary outcomes
- Safety assessment: Registration of adverse events; Efficacy Assessment: Evaluation of islet function
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 27 December 2024
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
The aim is to Investigate the safety and efficacy of Portal vein infusion Allogeneic Human umbilical cord mesenchymal stem cells combined with Allogeneic islet transplantation for the treatment of diabetes
Detailed description public domain (ClinicalTrials.gov)
This is an investigator-initiated trial (IIT). The first part is an open-label, dose-escalation study involving 9 patients between the ages of 18 and 70. The second part is a non-randomized, active comparator-controlled IIT with a parallel design, comparing allogeneic islet transplantation combined with human umbilical cord mesenchymal stem cells (hUCMSCs) to allogeneic islet transplantation alone in patients with diabetes.Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed.