Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DK099696 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently, the investigators intend to test whether infusion of MSCs immediately after islet autograft can reduce onset of diabetes and improve glycemic control after total pancreatectomy and islet autotransplantation.
This is a Phase I study evaluating safety and tolerability of autologous BM-MSCs in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT). CCT-BMMSC will be infused at one of the following doses: (Tier 1), 20x10^6 cell per patient, (Tier 2), 50x10^6 cell per patient, and (Tier 3), 100x10^6 cell per patient.
Primary objective: To describe and compare the safety and tolerability of infusion of fresh autologous bone marrow-derived Mesenchymal stromal cells after islet transplantation in chronic pancreatitis patients who undergo TP-IAT. The investigators plan to enroll 24 patients for the whole study. The duration of this study is 12 months. The investigators anticipate that this study will be completed within 2 years of commencement.
Secondary objective: Efficacy of infusion of fresh autologous bone marrow-derived Mesenchymal stromal cells together after islet transplantation in chronic pancreatitis patients who undergo TP-IAT as assessed through onset of diabetes, glycemic control, pain relief and quality of life index.
Safety variables: Adverse events (AEs), Laboratory parameters (hematology, biochemistry, urinalysis), Vital signs
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients will receive standard islet transplantation. | |
| autologous mesenchymal stromal cell | Experimental | Patients will receive MSCs together with standard islet transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous mesenchymal stromal cell | Biological | Islet transplantation patients will receive autologous MSCs following islets infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide level after mixed meal tolerance test | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function, kidney function | 12 months after transplant | |
| The absence of severe hypoglycemic episodes | 12 months after transplant |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hongjun Wang, Ph.D | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI Surgery, Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29159905 | Result | Wang H, Strange C, Nietert PJ, Wang J, Turnbull TL, Cloud C, Owczarski S, Shuford B, Duke T, Gilkeson G, Luttrell L, Hermayer K, Fernandes J, Adams DB, Morgan KA. Autologous Mesenchymal Stem Cell and Islet Cotransplantation: Safety and Efficacy. Stem Cells Transl Med. 2018 Jan;7(1):11-19. doi: 10.1002/sctm.17-0139. Epub 2017 Nov 21. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |