Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205342
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-01-04
Brief Title:
Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
STEMCAP-1 Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEMCAP-1
Brief Summary:
This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells BM-MSCs can reduce pain associated with chronic pancreatitis CP and explore potential mechanisms of MSC action
Detailed Description:
Chronic pancreatitis CP and chronic pain CP is a debilitating disease characterized by persistent pancreatic inflammation irreversible morphological changes fibrosis in the pancreas and severe chronic pain A progressive loss of exocrine and endocrine function occurs during disease progression The incidence of CP ranges from 16 to 23 cases per 100000 populations per year worldwide and is likely under diagnosed in the general population CP in the United States results in more than 122000 outpatient visits and more than 56000 hospitalizations per year The poorly understood pathophysiology of CP makes the identification of means to treat the underlying cellular disorder problematic Abdominal pain has been reported in at least 80-94 of patients The pain suffered by CP patients is among the worst encountered in medicine which often leads to opioid addiction Many CP patients require hospital admission at some stage in their illness The cause of pain is complex and is mostly unknown The pathophysiology in pain due to CP is multifactorial including peripheral nociception peripheralpancreatic neuropathy and neuroplasticity Achieving satisfactory pain relief remains a challenge Current management strategies have used a step-up approach in pain medications that often lead to opioid dependence Among all patients 40-75 patients will eventually require surgery after which only 34-52 attain pain relief after pancreas resection CP pain provides a useful model for the understanding of the mechanisms and treatment of pain syndromes with an identifiable nociceptive source in general as approximately 50 million US adults are suffering from pain Improving the management of CP pain may translate to other disease states with pain and opioid addiction
Mesenchymal stromal cells MSCs are adult stem cells that can be harvested and expanded for therapy MSC therapy is an investigational intervention for CP There is increasing evidence 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 Data from animal models and clinical trials support the outstanding and durable effects of MSC infusion in the suppression of chronic neurological pain and inflammation associated with knee osteoarthritis critical limb ischemia neuropathy diabetic neuropathy and others MSCs migrate to the spinal cord and pre-frontal cortex of neuropathic mice after injection and exert pain relief A recent study demonstrated that infusion of human MSCs significantly reduced pain improved pancreatic volume and reduced fibrosis in CP rodent models
Rationale of the study Because MSCs are a novel therapy that may improve chronic pancreatitis pain in animal models and improve chronic pain in other human disease states these cells are worthy of study This pilot study will give participants MSCs or placebo for CP subjects with pain This study will inform future study designs and may lead to MSCs as a standard of care if they are safe and effective
Mesenchymal stromal cells MSCs are adult stem cells that can be harvested and expanded for therapy MSC therapy is an investigational intervention for CP There is increasing evidence 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 Data from animal models and clinical trials support the outstanding and durable effects of MSC infusion in the suppression of chronic neurological pain and inflammation associated with knee osteoarthritis critical limb ischemia neuropathy diabetic neuropathy and others MSCs migrate to the spinal cord and pre-frontal cortex of neuropathic mice after injection and exert pain relief A recent study demonstrated that infusion of human MSCs significantly reduced pain improved pancreatic volume and reduced fibrosis in CP rodent models
Rationale of the study Because MSCs are a novel therapy that may improve chronic pancreatitis pain in animal models and improve chronic pain in other human disease states these cells are worthy of study This pilot study will give participants MSCs or placebo for CP subjects with pain This study will inform future study designs and may lead to MSCs as a standard of care if they are safe and effective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UG3DK136705-01 | NIH | None | httpsreporternihgovquickSearch1UG3DK136705-01 |