Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT

NCT05095532 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: Pro00099487R01DK126454
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial for chronic pancreatitis (CP) patients undergoing total pancreatectomy with islet autotransplantation (TP-IAT). Participants will be randomized to either bone marrow-derived mesenchymal stem cells (MSCs) or control with the standard of care. Participants will be followed for one-year post-transplant.

Conditions

Mesenchymal Stem Cells; Chronic Pancreatitis

Keywords

Total Pancreatectomy; TP-IAT

Outcome Measures

Primary Outcomes (1)

• Change in Islet Cell Function

  The primary endpoint will be change in islet function between baseline and 12 months as measured by area under the curve of C-peptide levels during a mixed meal tolerance test (MMTT) adjusted by islet equivalent number (IEQ) transplanted.

  1 year

Secondary Outcomes (4)

• Change in HbA1C levels from baseline to 12 months.

  1 year

• Proportion of insulin-independent patients following IAT

  1 year

• Average daily insulin requirement

  1 year

• Beta cell function as assessed by beta-score

  1 year

Other Outcomes (6)

• Change in islet function between baseline to day 90±28

  90 days

• Daily oral Morphine Equivalents on day prior to visit

  9 months

• Proportion of patients remaining on narcotics

  9 months

Study Arms (3)

BM-MSCs at 20x10^6

EXPERIMENTAL

One time infusion of islets plus BM-MSCs at 20x10\^6/patient, n=14

Biological: Bone marrow-derived mesenchymal stem cells

BM-MSCs at 50x10^6

EXPERIMENTAL

One time infusion of islets plus BM-MSCs at 50x10\^6/patient, n=14

Biological: Bone marrow-derived mesenchymal stem cells

Placebo

PLACEBO COMPARATOR

One time infusion of islets only.

Other: Placebo

Interventions

Bone marrow-derived mesenchymal stem cells BIOLOGICAL

MSC transplantation

BM-MSCs at 20x10^6; BM-MSCs at 50x10^6

Placebo OTHER

Standard of Care

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CP and scheduled for TP-IAT;
• ≥18 years old;
• Diabetes with HbA1c \<12%.

You may not qualify if:

• Patients who are under immunosuppression;
• Pregnant and breastfeeding women.
• Patients who have liver damage based on ALT, AST, and total bilirubin levels (\>3 times normal levels);

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (6)

• Sutherland DE, Gruessner AC, Carlson AM, Blondet JJ, Balamurugan AN, Reigstad KF, Beilman GJ, Bellin MD, Hering BJ. Islet autotransplant outcomes after total pancreatectomy: a contrast to islet allograft outcomes. Transplantation. 2008 Dec 27;86(12):1799-802. doi: 10.1097/TP.0b013e31819143ec.

  PMID: 19104425 BACKGROUND

• Morgan KA, Lancaster WP, Owczarski SM, Wang H, Borckardt J, Adams DB. Patient Selection for Total Pancreatectomy with Islet Autotransplantation in the Surgical Management of Chronic Pancreatitis. J Am Coll Surg. 2018 Apr;226(4):446-451. doi: 10.1016/j.jamcollsurg.2017.12.018. Epub 2017 Dec 28.

  PMID: 29289751 BACKGROUND

• Wang J, Zhang Y, Cloud C, Duke T, Owczarski S, Mehrotra S, Adams DB, Morgan K, Gilkeson G, Wang H. Mesenchymal Stem Cells from Chronic Pancreatitis Patients Show Comparable Potency Compared to Cells from Healthy Donors. Stem Cells Transl Med. 2019 May;8(5):418-429. doi: 10.1002/sctm.18-0093. Epub 2019 Jan 24.

  PMID: 30680957 BACKGROUND

• Song L, Sun Z, Kim DS, Gou W, Strange C, Dong H, Cui W, Gilkeson G, Morgan KA, Adams DB, Wang H. Adipose stem cells from chronic pancreatitis patients improve mouse and human islet survival and function. Stem Cell Res Ther. 2017 Aug 30;8(1):192. doi: 10.1186/s13287-017-0627-x.

  PMID: 28854965 BACKGROUND

• Ryan EA, Paty BW, Senior PA, Lakey JR, Bigam D, Shapiro AM. Beta-score: an assessment of beta-cell function after islet transplantation. Diabetes Care. 2005 Feb;28(2):343-7. doi: 10.2337/diacare.28.2.343.

  PMID: 15677790 BACKGROUND

• Wang H, Desai KD, Dong H, Owzarski S, Romagnuolo J, Morgan KA, Adams DB. Prior surgery determines islet yield and insulin requirement in patients with chronic pancreatitis. Transplantation. 2013 Apr 27;95(8):1051-7. doi: 10.1097/TP.0b013e3182845fbb.

  PMID: 23411743 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlton Strange, M.D

  Medical University of South Carolina

  STUDY DIRECTOR

• William Lancaster, M.D

  Medical University of South Carolina

  STUDY DIRECTOR

• Hongjun Wang

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Benn, MPH

CONTACT

843-792-2813; bennle@musc.edu

Kelsey Cook

CONTACT

843 876 0420; conder@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Scientific Director, Center for Cellular Therapy

Model Details: This will be a randomized, controlled clinical trial in which CP patients scheduled for TP-IAT who meet the study criteria and consented will be randomized into three groups. One group will receive islet transplantation alone (n=14). The other two groups will receive islets plus BM-MSCs at two different doses (20x10\^6/patient, or 50x10\^6/patient, n=14 in each group).

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 27, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)