Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407297
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-16
Brief Title:
UCMSCs Combined With Standard Therapy for the Treatment of Newly Diagnosed Type 1 Diabetes
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
Investigation of Dose Escalation and Cohort Expansion Study on the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem CellsUCMSCs Combined With Standard Therapy for Newly Diagnosed Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim is to investigate the safety and tolerability of intravenous infusion of allogeneic umbilical cord mesenchymal stem cells in pediatric patients diagnosed with newly onset type 1 diabetes
Detailed Description:
This is an IIT study where the first part is an open dose escalating study consisting of 9 patients 8-18 years of age The second part is a randomized double-blinded placebo-controlled IIT study in parallel design comparing allogeneic UCMSCs treatment to placebo in pediatric patients diagnosed with newly onset type 1 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
A total number of 24 patients will be enrolled in the study and followed for one year after UCMSCsplacebo treatment Patients 8-18 years of age both male and female diagnosed for type 1 diabetes will be eligible Providing informed consent and fulfillment of inclusion criteria and no exclusion criteria they will within 6 months of diagnosis be randomized
A total number of 24 patients will be enrolled in the study and followed for one year after UCMSCsplacebo treatment Patients 8-18 years of age both male and female diagnosed for type 1 diabetes will be eligible Providing informed consent and fulfillment of inclusion criteria and no exclusion criteria they will within 6 months of diagnosis be randomized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None