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

NCT ID: NCT05095532

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2027-06-30

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.

Detailed Description

This will be a randomized, controlled clinical trial for CP patients scheduled to undergo a TP-IAT surgery. Those who are consented will be randomized into one of three groups. One group will receive islet transplantation alone, a placebo. The other two groups will receive islets plus autologous bone marrow-MSCs at two different doses (20x10^6/patient, or 50x10^6/patient). The TP-IAT procedure will remain as routinely performed. Patients will be followed for12 months post-transplantation, having 3 follow-up visits scheduled on days 90, 180, and 365 after the transplant. The primary endpoint will be a change in islet function from baseline to 12 months post-transplantation as measured by the C-peptide area under the curve following a mixed meal tolerance test. Potential effects of MSCs on glycemic control, pain relief, quality of life, and adverse events will be evaluated at each follow-up visit.

Conditions

Chronic Pancreatitis; Mesenchymal Stem Cells

Study Design

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

Study Groups

BM-MSCs at 20x10^6

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

Group Type: EXPERIMENTAL

Bone marrow-derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

MSC transplantation

BM-MSCs at 50x10^6

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

Group Type: EXPERIMENTAL

Bone marrow-derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

MSC transplantation

Placebo

One time infusion of islets only.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Standard of Care

Interventions

Bone marrow-derived mesenchymal stem cells

MSC transplantation

Intervention Type: BIOLOGICAL

Placebo

Standard of Care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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);

• Minimum Eligible Age: 18 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, Scientific Director, Center for Cellular Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charlton Strange, M.D

Role: STUDY_DIRECTOR

Medical University of South Carolina

William Lancaster, M.D

Role: STUDY_DIRECTOR

Medical University of South Carolina

Hongjun Wang

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leah Benn, MPH

Role: CONTACT

bennle@musc.edu

843-792-2813

Kelsey Cook

Role: CONTACT

conder@musc.edu

843 876 0420

Facility Contacts

Leah Benn, MPH

Role: primary

bennle@musc.edu

843-792-2813

References

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.

Reference Type: BACKGROUND

PMID: 15677790 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19104425 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29289751 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30680957 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28854965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23411743 (View on PubMed)

Other Identifiers

R01DK126454

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00099487

Identifier Type: -

Identifier Source: org_study_id