Could stem cells ease debilitating pancreas pain?
NCT ID NCT06205342
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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