Mesenchymal Stem Cells for Chronic Pancreatitis

(STEMCAP-1 Trial)

Overseen By Leah Benn

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Medical University of South Carolina

Must be taking: Opioids

Disqualifiers: Acute pancreatitis, Severe organ failure, HbA1c >10%, others

Compensation: Varies

Number of Visits: 4

Duration: 6 months

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a treatment using mesenchymal stem cells (special cells from bone marrow) can reduce pain for individuals with chronic pancreatitis, a condition causing long-term pain and inflammation in the pancreas. The trial compares the stem cell treatment to a placebo to assess its effectiveness. Individuals who have experienced painful chronic pancreatitis for over six months and have maintained a stable dose of pain medication may be suitable candidates for this trial. As an Early Phase 1 trial, this research aims to understand 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 does not specify if you need to stop taking your current medications. However, it requires that participants have been on a stable dose of opioids for the past 30 days, suggesting that you may need to continue your current opioid regimen.

What prior data suggests that this protocol is safe?

Research shows that mesenchymal stem cells (MSCs) might help treat pancreatitis. Animal studies suggest these cells could be beneficial, but their effectiveness in humans remains under investigation.

Regarding safety, limited information exists from human studies. This trial is in the early stages, so data on how people handle the treatment is scarce. Typically, if a treatment reaches this stage, it is considered safe enough for testing in a small group.

If mesenchymal stem cells have approval for other conditions, it suggests they might be safe for broader use. However, individual experiences can vary, and side effects may occur. As more research is conducted, understanding of safety will improve. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for chronic pancreatitis, which often revolve around pain management and enzyme supplements, mesenchymal stem cells (MSCs) offer a novel approach by potentially repairing damaged pancreatic tissue. Researchers are excited about MSCs because they have the ability to modulate the immune system and promote healing at the cellular level, which could address the root cause of the disease rather than just alleviating symptoms. This regenerative capability of MSCs represents a significant shift in how we might treat chronic pancreatitis in the future.

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

Research has shown that certain stem cells, called mesenchymal stem cells (MSCs), might help treat pancreatitis. Animal studies demonstrated that these cells can reduce swelling and aid in tissue repair. In human studies, MSCs have eased the pain of chronic pancreatitis. They appear to work by reducing inflammation and promoting the healing of damaged tissues. This trial will evaluate the effectiveness of MSCs in an experimental cohort, while a validation cohort will receive a placebo. Although more research is needed, early results suggest that MSCs might provide relief for those suffering from chronic pancreatitis pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Hongjun N Wang, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with chronic pancreatitis who experience ongoing pain. Participants should be adults who meet specific health criteria and have not responded well to standard pain treatments.

Inclusion Criteria

I have had chronic pancreatitis pain for over 6 months.

My opioid medication dose has been the same for the last 30 days.

Baseline Izbicki pain score > 30

Exclusion Criteria

Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days.

Score >7 on the Opioid Risk Tool

HbA1c >10%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) or placebo

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mesenchymal Stem Cells

Trial Overview

The study is testing the safety and effectiveness of mesenchymal stem cells (MSCs) derived from bone marrow in reducing chronic pancreatitis pain, compared to a 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?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Adipose-derived mesenchymal stem cells (ASCs) significantly reduced pancreatic damage and fibrosis in a chronic pancreatitis mouse model, indicating their potential efficacy in treating this condition.

The study demonstrated that ASCs not only migrated to the pancreas and differentiated into acinar-like cells but also suppressed inflammation and tissue damage, suggesting a dual mechanism of action for their therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose Stem Cell Therapy Mitigates Chronic Pancreatitis via Differentiation into Acinar-like Cells in Mice. Sun, Z., Gou, W., Kim, DS., et al.[2023]

In a study of 60 patients with severe acute pancreatitis, those receiving mesenchymal stem cell therapy alongside standard treatment showed significant improvements in homeostasis, immune response, and microcirculation compared to those receiving only standard treatment.

The therapy was particularly effective in patients with the T774T mutation of the eNOS gene, suggesting that genetic factors may influence the efficacy of mesenchymal stem cell treatment in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cell therapy for destructive pancreatitis]. Gasanova, SY.[2022]

Mesenchymal stem cells (MSCs) derived from human pancreas exhibit a high potential for ex vivo expansion, capable of doubling in population every 30 hours and maintaining their characteristics over 30 passages, indicating their robustness for research and therapeutic applications.

These pancreatic MSCs can differentiate into multiple lineages, including osteogenic, adipogenic, and chondrogenic, demonstrating their versatility and potential for use in tissue engineering and regenerative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Identification and isolation of mesenchymal stem cells from human fetal pancreas]. Hu, Y., Wang, QY., Ma, L., et al.[2006]

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]

A meta-analysis of 152 randomized clinical trials involving 9228 individuals treated with mesenchymal stromal cells (MSCs) found that fever is the only adverse event closely associated with MSC therapy, with a significant odds ratio of 1.61.

The analysis also indicated that MSC therapy may lower the incidence of tachycardia and fatigue, although these findings were not statistically significant, suggesting a generally favorable safety profile for MSC treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient Fever: the Sole Treatment-Related Adverse Event associated with Mesenchymal Stromal Cells and Solid Clues from the Real World. Wang, Y., Mou, Q., Yi, H., et al.[2023]

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]

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) 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]

A review of 62 randomized clinical trials involving 3546 participants found that mesenchymal stem cell (MSC) therapy is generally safe, with no serious adverse events like death or infection reported.

While MSC therapy was associated with some mild adverse effects such as transient fever and fatigue, it also showed a trend towards reducing the incidence of arrhythmia, suggesting a favorable safety profile compared to placebo treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of MSC therapy over the past 15 years: a meta-analysis. Wang, Y., Yi, H., Song, Y.[2021]

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