Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT01413035
Status:
UNKNOWN
Last Update Posted:
2011-08-09
First Post:
2011-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Type 2 Diabetes
Sponsor:
Shandong University
Organization:
Study Overview
Official Title:
Safety/Efficacy Assessed Study on Transplantation Therapy Using Human Umbilical Cord/Placenta-derived Mesenchymal Stem Cells for Type 2 Diabetes Mellitus
Status:
UNKNOWN
Status Verified Date:
2011-07
Last Known Status:
RECRUITING
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 purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg for type 2 diabetes.
Detailed Description:
1\. Intervention Details: Biological: umbilical cord/placenta-derived mesenchymal stem cells; Drug: 1. Oral Hypoglycemic Drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. 2. Insulins.
1. 1st transplantation: after finishing all required examines according to protocol in Day 0, umbilical cord/placenta-derived MSCs are transplanted intravenously.
2. 2nd transplantation: after finishing all required examines in Day 90, umbilical cord/placenta-derived-MSCs are transplanted intravenously if the effects of MSC are better than that before.
3. At the same time, patients continue taking the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins which the patients have taken for controlling the higher blood sugar from Day 0 for 1 year. But the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar.
2\. Detailed Description:
1. To evaluate the feasibility and safety of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins.
2. To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins.
3. This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant and the oral hypoglycemic drugs or MSC transplant and insulins or MSC transplant and the combination of the oral hypoglycemic drugs and insulins (experimental group) or the oral hypoglycemic drugs or insulins or the combination of the oral hypoglycemic drugs and insulins (control group). Patients will undergo MSC transplant at the start of the study on Day 0 and take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. As control, some patients take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. At the same time, the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar. After 3 months, patients will receive the second MSC transplantation. After six and twelve months from the first transplantation, patients will be evaluated.
1. 1st transplantation: after finishing all required examines according to protocol in Day 0, umbilical cord/placenta-derived MSCs are transplanted intravenously.
2. 2nd transplantation: after finishing all required examines in Day 90, umbilical cord/placenta-derived-MSCs are transplanted intravenously if the effects of MSC are better than that before.
3. At the same time, patients continue taking the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins which the patients have taken for controlling the higher blood sugar from Day 0 for 1 year. But the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar.
2\. Detailed Description:
1. To evaluate the feasibility and safety of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins.
2. To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins.
3. This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant and the oral hypoglycemic drugs or MSC transplant and insulins or MSC transplant and the combination of the oral hypoglycemic drugs and insulins (experimental group) or the oral hypoglycemic drugs or insulins or the combination of the oral hypoglycemic drugs and insulins (control group). Patients will undergo MSC transplant at the start of the study on Day 0 and take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. As control, some patients take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. At the same time, the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar. After 3 months, patients will receive the second MSC transplantation. After six and twelve months from the first transplantation, patients will be evaluated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: