Mesenchymal Stem Cell and Islet Co-transplantation
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 69 |
| Updated: | 1/5/2019 |
| Start Date: | December 2014 |
| End Date: | December 2018 |
A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow-derived Mesenchymal Stromal Cells in Chronic Pancreatitis Patients Who Undergo Total Pancreatectomy and Islet Autotransplantation.
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.
(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
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
Inclusion Criteria:
- Chronic pancreatitis patients who undergo TP-IAT.
- >18 years of age.
- Patients with BMI from 18.5 to 30.
- Renal function: >90mls/min/1.73m squared
- Normal INR/PT/PTT values for MUSC clinical laboratory standards
- Diabetes free before surgery (fasting blood glucose<125mg/dl).
- No prior pancreatic surgery with the exception of transduodenal sphincteroplasty or
Whipple/Beger procedure.
- Patients with normal liver function as measured by serum levels of aminotransferase
including alanine aminotransferase (ALT), and aspartate aminotransferase (AST), and
total bilirubin levels.
Exclusion Criteria:
- Patients whose Hemoglobin, Hematocrit, and Platelet count are above or below normal
values for MUSC clinical laboratory standards.
- Patients who has hematological malignancy.
- Patients who are under immunosuppression.
- Patients with marked calcification disease on CT scan.
- Patients with severe fibrosis and atrophy on pancreas MRI.
We found this trial at
1
site
Charleston, South Carolina 29425
Phone: 843-876-4305
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