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Could stem cells ease debilitating pancreas pain?

NCT ID NCT06205342

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests if a single infusion of donor stem cells can reduce long-term pain from chronic pancreatitis. Researchers will enroll 48 adults with persistent pain and track changes in pain scores, opioid use, and quality of life over 6 months. The goal is to see if this approach is safe and offers meaningful relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age between 18 and 75 years old, male or female 2. Definite chronic pancreatitis 3. Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting. 4. Baseline Izbicki pain score \> 30 5. Stable dose of opioids for the past 30 days Exclusion Criteria: 1. Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days. * The revised Atlanta classification requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis, (b) serum amylase or lipase level greater than three times the upper normal value, or (c) characteristic imaging findings. 2. Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days. 3. Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months. 4. HbA1c \>10% 5. Laboratory values of WBC \<2.0 cells/10\^3, Hemoglobin \<8 gm/dl, and platelets \<100K cells/10\^3, AST or ALT \> 3 times the upper limit of normal, or creatinine \>2.0 mg/dl 6. New York Heart Association Class 2 or higher congestive heart failure 7. Current lung, hematologic, or solid organ malignancy other than skin, or cervical stage 1 cancers within the past 3 years. 8. Subjects with current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. 9. Active malignancy with the exception of non-melanoma skin cancer. 10. Any subject who has received an investigational drug or device within 30 days before randomization or who is expected to receive an investigational drug or device during this study. 11. Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months. 12. Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization related to pancreatitis within the last 90 days 13. Subjects who have had any ongoing alcohol abuse and/or any illegal drug abuse within the past 6 months. 14. Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent 15. Females who are pregnant or women of childbearing potential (WOCBP) and males with female partners of childbearing potential who are not willing to use adequate contraception during the study 16. Breastfeeding females 17. Subject unwilling to follow the protocol and assessments

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

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