Mesenchymal Stem Cell and Islet Co-transplantation

Diabetes Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384018
• Other study ID #: CCT-BMMSC15-001
• Secondary ID: 5R21DK099696
• Status: Completed
• Phase: Phase 1
• Start date: December 2014
• Est. completion date: November 21, 2017

Study information

• Verified date: March 2022
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 21, 2017
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Diabetes
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Biological:
• autologous mesenchymal stromal cell
Islet transplantation patients will receive autologous MSCs following islets infusion

Locations

Country	Name	City	State
United States	GI Surgery, Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Cell — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide level after mixed meal tolerance test		12 months
Secondary	Liver function, kidney function		12 months after transplant
Secondary	The absence of severe hypoglycemic episodes		12 months after transplant