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Mesenchymal Stem Cell + Islet Transplant for Chronic Pancreatitis

Phase 1
Recruiting
Led By Hongjun Wang
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years old
Diagnosis of CP and scheduled for TP-IAT
Must not have
Patients who have liver damage based on ALT, AST, and total bilirubin levels (>3 times normal levels)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year

Summary

This trial is for CP patients who are having their pancreas removed. They will be given either MSCs or the standard of care. They will be followed for a year afterwards.

Who is the study for?
This trial is for adults over 18 with chronic pancreatitis, scheduled for a specific surgery (TP-IAT), and have not had major pancreatic surgeries or diabetes before the surgery. It's not for those with significant liver damage, prior certain pancreatic surgeries that affect islet yield, or women who are pregnant/breastfeeding. People under immunosuppression are also excluded.
What is being tested?
The study tests if bone marrow-derived mesenchymal stem cells can help patients recovering from TP-IAT surgery compared to the standard care without these cells. Participants will be randomly assigned to receive either the stem cells or a placebo and monitored for one year.
What are the potential side effects?
Potential side effects of receiving mesenchymal stem cells may include immune system reactions, infection risk at injection site, and possible influence on tumor growth although rare. The exact side effects in this context are still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have chronic pancreatitis and am scheduled for a total pancreatectomy with islet autotransplantation.
Select...
My diabetes is under control with an HbA1c level below 12%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My liver tests show damage more than three times the normal levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Islet Cell Function
Secondary study objectives
Insulin
Beta cell function as assessed by beta-score
Change in HbA1C levels from baseline to 12 months.
+1 more
Other study objectives
Change in islet function between baseline to day 90±28
Morphine
C-Peptide
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BM-MSCs at 50x10^6Experimental Treatment1 Intervention
One time infusion of islets plus BM-MSCs at 50x10\^6/patient, n=14
Group II: BM-MSCs at 20x10^6Experimental Treatment1 Intervention
One time infusion of islets plus BM-MSCs at 20x10\^6/patient, n=14
Group III: PlaceboPlacebo Group1 Intervention
One time infusion of islets only.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
973 Previous Clinical Trials
7,399,341 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,377 Total Patients Enrolled
Charlton Strange, M.DStudy DirectorMedical University of South Carolina

Media Library

Bone marrow-derived mesenchymal stem cells Clinical Trial Eligibility Overview. Trial Name: NCT05095532 — Phase 1
Bone marrow-derived mesenchymal stem cells 2023 Treatment Timeline for Medical Study. Trial Name: NCT05095532 — Phase 1
Chronic Pancreatitis Research Study Groups: BM-MSCs at 20x10^6, Placebo, BM-MSCs at 50x10^6
Chronic Pancreatitis Clinical Trial 2023: Bone marrow-derived mesenchymal stem cells Highlights & Side Effects. Trial Name: NCT05095532 — Phase 1
~15 spots leftby Jun 2026
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