Could your own stem cells ease pancreatitis pain?
NCT ID NCT05925036
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests whether stem cells taken from a patient's own bone marrow can reduce pain caused by chronic pancreatitis and possibly improve pancreas function. Forty adults with long-term painful pancreatitis will receive either the stem cells or a placebo. The study focuses on safety and pain changes over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mesenchymal stem cells (MSCs) from the patient's own bone marrow
- What this could lead to
- If it works, this could point toward a new way to manage chronic pain and improve quality of life for people with chronic pancreatitis.
- What could go wrong
- This is an early Phase 1 trial with only 40 participants, so it is too soon to know if it works. The main goal is safety, and pain relief may not be achieved.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
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: * Age between 18 and 75 years old, male or female * Definite chronic pancreatitis M-ANNHEIM criteria (Tsimmerman Ia, 2008) One or more of the following are required: * Pancreatic calcifications * Moderate or marked ductal lesions * Marked and persistent exocrine insufficiency defined as pancreatic steatorrhea markedly reduced by enzyme supplementation * Typical histology of an adequate histological specimen * Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting. * Baseline Izbicki pain score \> 30 (Dworkin et al., 2005) * Stable dose of opioids for the past 30 days Exclusion Criteria: * Acute pancreatitis per 2012 revised Atlanta criteria (23) within the last 30 days oThe 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. * Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days. * Hemoglobin of \<8.0g/dL, EGFR\<60 ml/min, AST or ALT \>2 times upper limit of normal, Bilirubin \> 1.5 mg/dl unless the subject has confirmed Gilbert syndrome., Platelets \<100,000/microliter, HbA1c \>10% * Congestive Heart Failure NYHA class \>1 * History of Malignancy except for in situ malignancies that have been surgically treated and basal cell skin cancers * Evidence of active infection using current antibiotics or with Hepatitis B, C, or HIV * Known intravenous contrast allergy causing anaphylaxis * Any subject who has had an ongoing alcohol abuse and/or illegal drug dependencies within the past six months. * 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. * Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months. * Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent * 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 * Breastfeeding females * Subject unwilling to follow the protocol and assessment
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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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Ralph H. Johnson VA Medical Center, Charleston, SC
RECRUITINGCharleston, South Carolina, 29401-5703, United States
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