Mesenchymal Stem Cell and Islet Co-transplantation

NCT ID: NCT02384018

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-11-21

Brief 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.

Detailed 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

Conditions

Chronic Pancreatitis; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

Patients will receive standard islet transplantation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

autologous mesenchymal stromal cell

Patients will receive MSCs together with standard islet transplantation.

Group Type: EXPERIMENTAL

autologous mesenchymal stromal cell

Intervention Type: BIOLOGICAL

Islet transplantation patients will receive autologous MSCs following islets infusion

Interventions

autologous mesenchymal stromal cell

Islet transplantation patients will receive autologous MSCs following islets infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Hongjun Wang

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongjun Wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

GI Surgery, Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29159905 (View on PubMed)

Other Identifiers

5R21DK099696

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCT-BMMSC15-001

Identifier Type: -

Identifier Source: org_study_id