Cellular Therapy for Chronic Pancreatitis Pain

(MSCPainRelief Trial)

Overseen By Leah Benn

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: VA Office of Research and Development

Must be taking: Opioids

Must not be taking: Antibiotics

Disqualifiers: Acute pancreatitis, Chronic pain syndromes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if stem cells from a patient's own bone marrow can reduce pain and improve function in individuals with chronic pancreatitis, a condition causing severe and long-lasting inflammation of the pancreas. Participants will receive either the mesenchymal stem cell treatment or a placebo (a non-active substance) to compare results. It suits those who have experienced painful chronic pancreatitis for over six months and have maintained a stable dose of pain medication. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires participants to have a stable dose of opioids for the past 30 days, so you may need to maintain your current opioid medication if you are taking it. The protocol does not specify other medication restrictions.

Is there any evidence suggesting that mesenchymal stem cells are likely to be safe for humans?

Research has shown that mesenchymal stem cells (MSCs) have been tested in various studies to assess their safety in humans. Early results suggest that MSCs are generally safe. In studies using MSCs, most patients did not experience serious side effects. Some minor side effects, such as temporary pain at the injection site or a mild fever, have been noted, but these were uncommon.

This trial, being in its early stages, primarily aims to confirm the safety of MSCs for treating pain from chronic pancreatitis. Early-stage trials typically focus on safety, so reaching this point suggests some confidence in MSC safety. However, ongoing monitoring remains crucial to ensure the safety of all participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for chronic pancreatitis pain, which typically include pain relievers and enzyme supplements, mesenchymal stem cells (MSCs) offer a novel approach. MSCs are unique because they have the ability to reduce inflammation and promote tissue repair at the cellular level. This new mechanism of action could potentially address the root cause of pain rather than just managing symptoms. Researchers are excited about MSCs as they hold promise for long-lasting relief and improved quality of life for patients with chronic pancreatitis.

What evidence suggests that mesenchymal stem cells might be an effective treatment for chronic pancreatitis pain?

Research shows that certain stem cells, called mesenchymal stem cells (MSCs), may help treat long-lasting pain, including pain from chronic pancreatitis. Animal studies have found that MSCs can lessen pain and improve pancreatic function. These stem cells likely help by reducing swelling and aiding healing in the pancreas. MSCs have also successfully treated chronic pain in other human conditions. In this trial, participants in the experimental cohort will receive MSCs, while those in the validation cohort will receive a placebo. Although research on their use for chronic pancreatitis in humans is still developing, early findings are promising. ^{1 5 6 7 8}

Who Is on the Research Team?

Hongjun N Wang, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with chronic pancreatitis, experiencing pain for over 6 months and on a stable opioid dose. They must have certain pancreatic conditions confirmed by M-ANNHEIM criteria but can't join if they've had acute pancreatitis recently, high opioid risk, severe anemia or liver issues, uncontrolled diabetes, heart failure, are pregnant/breastfeeding or unwilling to use contraception.

Inclusion Criteria

Your pain score is higher than 50 before starting the study.

My pancreas shows signs of severe damage or changes.

I have had chronic pancreatitis pain for over 6 months.

Exclusion Criteria

I have had cancer before, but it was either skin cancer or treated early and surgically.

I am scheduled for a procedure on my pancreas within the next 6 months.

I am not pregnant or willing to use birth control during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mesenchymal stem cells (MSCs) or placebo to assess pain outcomes

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in quality of life and pancreatic volume

6 months

Long-term Follow-up

Participants are further monitored for changes in quality of life, pancreatic volume, and opioid use

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Mesenchymal stem cells

Trial Overview The study tests mesenchymal stem cells from the patient's bone marrow against a placebo to see if they reduce pain and improve pancreatic function in those with chronic pancreatitis. Participants will be randomly assigned to receive either the stem cells or placebo.

How Is the Trial Designed?

Group I: Experimental Cohort Experimental Treatment 1 Intervention

MSC

Group II: Validation Cohort Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

hAAT-MSCs (mesenchymal stromal cells overexpressing human alpha-1 antitrypsin) showed better preservation of pancreatic morphology and reduced pain sensitivity in chronic pancreatitis (CP) mouse models compared to native MSCs, indicating their potential for improved treatment outcomes.

Both hAAT-MSCs and native MSCs effectively reduced abdominal pain and inflammation in CP, but hAAT-MSCs demonstrated a trend towards greater pain relief and better pancreatic health, suggesting they may offer enhanced therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Cellular Therapy to Treat Pancreatic Pain in Experimental Chronic Pancreatitis Using Human Alpha-1 Antitrypsin Overexpressing Mesenchymal Stromal Cells. Chow, RP., Nguyen, K., Gou, W., et al.[2022]

Mesenchymal stem cells (MSCs) have shown promise in regenerative medicine due to their ability to secrete bioactive molecules that exert anti-inflammatory effects, making them a potential treatment for various gastrointestinal diseases, including acute and chronic pancreatitis.

Current research indicates that MSC therapy could effectively suppress inflammation in pancreatitis, although the specific mechanisms by which MSCs exert their therapeutic effects are still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell therapy for acute and chronic pancreatitis. Kawakubo, K., Ohnishi, S., Kuwatani, M., et al.[2021]

Stem cell therapy shows promise for treating acute and chronic pancreatitis by potentially aiding in regeneration and preventing further pancreatic and organ injury, which could reduce complications associated with these conditions.

Research indicates that stem cells possess immunomodulatory properties, and various studies in animal models support their clinical potential in managing pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem cell therapy: a potential for the perils of pancreatitis. Chela, H., Romana, BS., Madabattula, M., et al.[2021]

Mesenchymal stem cells (MSCs) show promise in treating acute pancreatitis (AP) due to their anti-inflammatory effects and ability to repair tissue damage, which is crucial as AP cases are rising globally and can lead to severe complications.

Induced mesenchymal stem cells (iMSCs) offer a standardized preparation method and large-scale production potential, making them a more viable option for commercialization compared to MSCs from varied sources like bone marrow or umbilical cord blood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of diagnosis and Mesenchymal stem cells therapy for acute pancreatitis. Munir, F., Jamshed, MB., Shahid, N., et al.[2023]

Human bone marrow-derived clonal mesenchymal stem cells (hcMSCs) showed significant potential in reducing inflammation and tissue damage in rat models of both mild and severe acute pancreatitis (AP), indicating their therapeutic efficacy.

Infusion of hcMSCs led to a decrease in inflammatory mediators and an increase in regulatory T cells (Foxp3+), suggesting a mechanism of action that involves modulating the immune response to promote healing in pancreatic tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human bone marrow-derived clonal mesenchymal stem cells inhibit inflammation and reduce acute pancreatitis in rats. Jung, KH., Song, SU., Yi, T., et al.[2022]

Bone marrow mesenchymal stem cells (bmMSCs) significantly reduced pancreatic injury and associated lung damage in a rat model of acute pancreatitis, as evidenced by lower levels of inflammatory cytokines and improved pancreatic histology.

The protective effects of bmMSCs are linked to their ability to regulate the release of inflammatory cytokines through the NF-κB p65 signaling pathway, although they do not actively migrate to the inflamed pancreas but are passively trapped in related organs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of bone marrow mesenchymal stem cells in L-arg-induced acute pancreatitis: effects and possible mechanisms. Yin, G., Hu, G., Wan, R., et al.[2022]

Mesenchymal stromal cells (MSCs) show promise in treating pancreatitis, particularly in reducing inflammation in acute cases and fibrosis in chronic cases, based on a review of 18 studies.

However, due to significant variability in the types, sources, and dosages of MSCs used across studies, there is currently no consensus on the best type of MSCs for treatment, and no clinical trials have been conducted to further investigate their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesenchymal Stromal Cell Therapy for Pancreatitis: A Systematic Review. Ahmed, SM., Morsi, M., Ghoneim, NI., et al.[2022]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/450596

Safety and Efficacy of Mesenchymal Stem Cells Associated ... This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) can reduce pain ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05925036

Study Details | NCT05925036 | Novel Cellular Therapy for ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5878867/

Mesenchymal Stromal Cell Therapy for Pancreatitis Based on animal studies, adult mesenchymal stromal cells (MSCs) are promising for the treatment of pancreatitis.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06205342/safety-and-efficacy-of-mesenchymal-stem-cells-associated-with-chronic-pancreatitis-pain

Safety and Efficacy of Mesenchymal Stem Cells Associated ... ... derived mesenchymal stromal cells (BM-MSCs) can reduce pain associated with chronic pancreatitis (CP) and explore potential mechanisms of MSC

5. nature.com nature.com/articles/s41392-025-02313-9

Mesenchymal stem cells in treating human diseases This review delves into the molecular mechanisms, signaling pathways, and regulatory factors that underpin the therapeutic effects of MSCs. This ...

6. ctv.veeva.com ctv.veeva.com/study/safety-and-efficacy-of-mesenchymal-stem-cells-associated-with-chronic-pancreatitis-pain

Safety and Efficacy of Mesenchymal Stem Cells Associated ... This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) can reduce pain ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05925036

Novel Cellular Therapy for the Treatment of Pain ... 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 ...

8. reporter.nih.gov reporter.nih.gov/project-details/11179488

Project Details - NIH RePORTER Based on compelling data, our hypothesis is that treatment with MSCs reduces chronic pain and improves pancreatic fibrosis and function by their ability to ...