Chronic PancreatitisPhase 1MSCPainReliefNCT05925036
Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
A Phase 1 study testing Mesenchymal stem cells in people with Chronic Pancreatitis and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pancreatitis, Chronic Pain
- What is being tested?
- Mesenchymal stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
Hongjun N Wang, PhD, 843-792-1800, hongjun.wang@va.gov
Richard A Schatz, MD, (843) 789-7472, Richard.Schatz@va.gov
About this study
The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function.
Read the detailed description
Chronic pain affects approximately 50 million U.S. adults and disproportionally impacts about 20 million veterans; 1 in 3 Veterans have been diagnosed with a condition related to chronic pain. There is also a significant interaction between chronic pain, post-traumatic stress disorder (PTSD), and persistent post-concussive syndromes common to the veteran population. The opioids that are prescribed to treat chronic pain are often ineffective and are associated with a significantly increased risk of misuse, addiction, diversion, overdose, and death. Unconventional treatment options that can effectively manage pain and avoid or reduce opioid addiction in Veterans are of significant clinical importance to VA healthcare. Given the high morbidity and mortality attributable to pain therapy, not to mention the staggering medical cost, it is vital to the VA healthcare mission to explore novel strategies to treat chronic pain effectively. Chronic pancreatitis (CP) is an inflammatory disease characterized by pancreatic inflammation, fibrosis, and abdominal pain. CP subjects often suffer extreme pain, which often leads to opioid addiction. In our animal models, the investigators show a linkage between inflammatory increases in neuropeptides and pain. In humans, the investigators have more specific pain measurements to explore the link between inflammation, neuropeptides, and neuropathic pain measurement as impacted by a novel therapeutic.
Mesenchymal stromal cells (MSCs) are adult stem cells that can be harvested and expanded for therapy. MSC therapy represents a promising new intervention as increasing evidence demonstrates that MSC therapy can effectively target several injury pathways in a variety of fibroinflammatory diseases and can reduce pain while suppressing inflammation, something that most pharmacological interventions cannot accomplish.
Rationale of the study: Because MSCs are a novel therapy that my improve chronic pancreatitis pain in animal models and improve chronic pain in other human disease states, these cells are worthy of study. Specifically, the investigators propose a pilot phase 1 crossover study design in which MSCs or placebo are prospectively given to CP subjects with pain outcomes measured. This phase 1 study will inform future study designs and may lead to MSCs as a standard of care if they are safe and effective.
- Conditions
- Chronic Pancreatitis, Chronic Pain
- Being tested
- Mesenchymal stem cells, Placebo
- Keywords
- Mesenchymal stem cells (MSCs), Chronic pancreatitis, Pain relief, Pancreas dysfunction, Fibrosis
- Medical subject headings
- Pancreatitis, Chronic, Chronic Pain, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsDrug
Also called MSCs
Autologous bone marrow derived MSCs
PlaceboOther
Also called Control
Controls
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cohort | Experimental | MSC Receives: Drug: Mesenchymal stem cells |
| Validation Cohort | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Izbicki pain score (M6 vs. Baseline)
Change in pain as measured by Izbicki pain scores
Measured: 6 month
Secondary outcomes (4)
Change in pancreatic volume measured by blinded scoring of MRI
Pancreas volume change
Measured: Screening, 6 months and 12 months
Change in opioid use as measured in average daily morphine equivalents.
Average Daily morphine Equivalent.
Measured: Screening, 6 and 12 months
Change in quality of life
Quality of life to be measured by Promise-29-v 2.1
Measured: Screening, 6 and 12 months
Change in M-Manheim Severity Index absolute score
Severity of Index absolute scores
Measured: Screening, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of a single intravenous infusion of autologous bone marrow-derived mesenchymal stromal cells in subjects with painful chronic pancreatitis.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hongjun N Wang, PhD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925036
- Sponsor's protocol ID
- NURP-003-22F
- Other IDs
- I01CX002516
- Acronym
- MSCPainRelief
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT05925036
- Acronym / sponsor ID
- MSCPainRelief / NURP-003-22F
- Conditions
- Chronic Pancreatitis, Chronic Pain
- Keywords
- Mesenchymal stem cells (MSCs), Chronic pancreatitis, Pain relief, Pancreas dysfunction, Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function.
Detailed description
Chronic pain affects approximately 50 million U.S. adults and disproportionally impacts about 20 million veterans; 1 in 3 Veterans have been diagnosed with a condition related to chronic pain. There is also a significant interaction between chronic pain, post-traumatic stress disorder (PTSD), and persistent post-concussive syndromes common to the veteran population. The opioids that are prescribed to treat chronic pain are often ineffective and are associated with a significantly increased risk of misuse, addiction, diversion, overdose, and death. Unconventional treatment options that can effectively manage pain and avoid or reduce opioid addiction in Veterans are of significant clinical importance to VA healthcare. Given the high morbidity and mortality attributable to pain therapy, not to mention the staggering medical cost, it is vital to the VA healthcare mission to explore novel strategies to treat chronic pain effectively. Chronic pancreatitis (CP) is an inflammatory disease characterized by pancreatic inflammation, fibrosis, and abdominal pain. CP subjects often suffer extreme pain, which often leads to opioid addiction. In our animal models, the investigators show a linkage between inflammatory increases in neuropeptides and pain. In humans, the investigators have more specific pain measurements to explore the link between inflammation, neuropeptides, and neuropathic pain measurement as impacted by a novel therapeutic.
Mesenchymal stromal cells (MSCs) are adult stem cells that can be harvested and expanded for therapy. MSC therapy represents a promising new intervention as increasing evidence demonstrates that MSC therapy can effectively target several injury pathways in a variety of fibroinflammatory diseases and can reduce pain while suppressing inflammation, something that most pharmacological interventions cannot accomplish.
Rationale of the study: Because MSCs are a novel therapy that my improve chronic pancreatitis pain in animal models and improve chronic pain in other human disease states, these cells are worthy of study. Specifically, the investigators propose a pilot phase 1 crossover study design in which MSCs or placebo are prospectively given to CP subjects with pain outcomes measured. This phase 1 study will inform future study designs and may lead to MSCs as a standard of care if they are safe and effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of a single intravenous infusion of autologous bone marrow-derived mesenchymal stromal cells in subjects with painful chronic pancreatitis.
| Arm | Type | Receives |
|---|---|---|
| Experimental Cohort | Experimental | Drug: Mesenchymal stem cellsMSC |
| Validation Cohort | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cellsAlso: MSCsAutologous bone marrow derived MSCs | Drug | Experimental Cohort |
| PlaceboAlso: ControlControls | Other | Validation Cohort |
Primary outcome
Change in Izbicki pain score (M6 vs. Baseline)
Time frame: 6 month
Change in pain as measured by Izbicki pain scores
4 secondary outcomes
Change in pancreatic volume measured by blinded scoring of MRI
Time frame: Screening, 6 months and 12 months
Change in opioid use as measured in average daily morphine equivalents.
Time frame: Screening, 6 and 12 months
Change in quality of life
Time frame: Screening, 6 and 12 months
Change in M-Manheim Severity Index absolute score
Time frame: Screening, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongjun N Wang, PhD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal stem cells in people with Chronic Pancreatitis and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leah Benn ((843) 792-2813, leah.benn@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Izbicki pain score (M6 vs. Baseline) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.