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| ID | Type | Description | Link |
|---|---|---|---|
| I01CX002516 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Cohort | Experimental | MSC |
|
| Validation Cohort | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cells | Drug | Autologous bone marrow derived MSCs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Izbicki pain score (M6 vs. Baseline) | Change in pain as measured by Izbicki pain scores | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pancreatic volume measured by blinded scoring of MRI | Pancreas volume change | Screening, 6 months and 12 months |
| Change in opioid use as measured in average daily morphine equivalents. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leah Benn | Contact | (843) 792-2813 | leah.benn@va.gov | |
| Alison B Neely | Contact | (843) 829-2110 | 1003 | alison.neely@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Hongjun N Wang, PhD | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Recruiting | Charleston | South Carolina | 29401-5703 | United States |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D059350 | Chronic Pain |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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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.
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Double blind.
| Placebo | Other | Controls |
|
|
Average Daily morphine Equivalent.
| Screening, 6 and 12 months |
| Change in quality of life | Quality of life to be measured by Promise-29-v 2.1 | Screening, 6 and 12 months |
| Change in M-Manheim Severity Index absolute score | Severity of Index absolute scores | Screening, 6 and 12 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |