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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am 18 years old or older.

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I have chronic pancreatitis and am scheduled for a total pancreatectomy with islet autotransplantation.

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My diabetes is under control with an HbA1c level below 12%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Islet Cell Function

Secondary outcome measures

Insulin

Beta cell function as assessed by beta-score

Change in HbA1C levels from baseline to 12 months.

+1 more

Other outcome measures

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,593 Total Patients Enrolled

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

2,359 Previous Clinical Trials

4,315,453 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently enrolling volunteers?

"Affirmative. The information available on clinicaltrials.gov implies that this medical experiment is currently attempting to recruit patients, having initially been posted on December 1st 2021 and recently updated in March 23rd 2022. They require 42 individuals from a single site for the study to be completed successfully."

Answered by AI

How many participants will be included in this research initiative?

"Affirmative. Based on the information found on clinicaltrials.gov, this medical study is actively seeking participants and was initially published December 1st 2021. The most recent version of the trial was uploaded March 23rd 2022 with a requirement for 42 volunteers from one site to join in the experiment."

Answered by AI

Has the FDA sanctioned Bone marrow-derived mesenchymal stem cells as a therapeutic technique?

"The safety of Bone marrow-derived mesenchymal stem cells is rated 1 due to the limited amount of data available, as this is a Phase 1 trial suggesting minimal evidence in regards to efficacy and safety."

Answered by AI