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Cell Therapy

Experimental Cohort for Chronic Pancreatitis (STEMCAP-1 Trial)

Q: Are individuals above the age of 60 eligible to participate in this clinical trial?

<p>To be eligible for this clinical trial, potential participants must fall within the age range of 18 to 75. It is worth noting that there are a total of 47 trials specifically targeting individuals under the age of 18 and an additional 420 trials focused on those over the age of 65.</p>

Q: Are researchers currently seeking participants for this study?

<p>According to the information provided on clinicaltrials.gov, this particular clinical trial is not currently actively seeking participants. The initial posting date was May 1st, 2024 and it was last edited on January 4th, 2024. However, there are currently a total of 469 other ongoing clinical trials that are actively recruiting patients at this time.</p>

Phase < 1

Waitlist Available

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

Age between 18 and 75 years old, male or female

Definite chronic pancreatitis (stage 1-3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, 1 month, 3 month, 6 month

Awards & highlights

STEMCAP-1 Trial Summary

This trial will test if an infusion of a specific type of cells can help reduce pain in people with chronic pancreatitis. It will also study how these cells work to reduce pain.

Who is the study for?

This trial is for individuals with chronic pancreatitis who experience ongoing pain. Participants should be adults who meet specific health criteria and have not responded well to standard pain treatments.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of mesenchymal stem cells (MSCs) derived from bone marrow in reducing chronic pancreatitis pain, compared to a placebo.See study design

What are the potential side effects?

Possible side effects may include reactions at the infusion site, fever, allergic responses, or body aches. The full range of side effects will be studied.

STEMCAP-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Select...

I have been diagnosed with chronic pancreatitis.

Select...

My opioid medication dose has been the same for the last 30 days.

STEMCAP-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, 1 month, 3 month, 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, 1 month, 3 month, 6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, 1 month, 3 month, 6 month 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 Izbicki pain score (M6 vs. Baseline)

Secondary outcome measures

Change in M-Manheim Severity Index absolute score

Change in opioid use as measured in average daily morphine equivalents.

Change in pancreatic volume measured by blinded scoring of MRI

+1 more

Side effects data

From 2020 Phase 1 trial • 14 Patients • NCT02866721

33%

Cough

33%

Diarrhea

33%

Non-cardiac Chest Pain

33%

Risk of Pathogen Exposure

33%

Myalgia

33%

Vomiting

33%

Increased Sputum Production

33%

Abdominal Pain

33%

Change in Appetite

33%

Generalized Pain

33%

Lethargy

33%

Hypomagnesemia

33%

Syncope

33%

PICC Line Insertion

33%

Cystic Fibrosis Pulmonary Exacerbation

33%

Constipation

33%

PICC Line Right Upper Extremity

100%

80%

60%

40%

20%

Study treatment Arm

1 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram

3 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram

5 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram

STEMCAP-1 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental CohortExperimental Treatment1 Intervention

MSC

Group II: Validation CohortPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesenchymal Stem Cells

2016

Completed Phase 2

~200

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

936 Previous Clinical Trials

7,396,790 Total Patients Enrolled

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

2,364 Previous Clinical Trials

4,315,354 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals above the age of 60 eligible to participate in this clinical trial?

"To be eligible for this clinical trial, potential participants must fall within the age range of 18 to 75. It is worth noting that there are a total of 47 trials specifically targeting individuals under the age of 18 and an additional 420 trials focused on those over the age of 65."

Answered by AI

Are researchers currently seeking participants for this study?

"According to the information provided on clinicaltrials.gov, this particular clinical trial is not currently actively seeking participants. The initial posting date was May 1st, 2024 and it was last edited on January 4th, 2024. However, there are currently a total of 469 other ongoing clinical trials that are actively recruiting patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain

Hongjun Wang 2024. "Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06205342.

All > Chronic Pancreatitis