Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925036
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-06-20
Brief Title:
Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
Status:
RECRUITING
Status Verified Date:
2024-02
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:
MSCPainRelief
Brief Summary:
The goal of this clinical trial is to test whether adult stem cells called mesenchymal stem cells MSCs collected from the patients bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function
Detailed Description:
Chronic pain affects approximately 50 million US 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
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 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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I01CX002516 | NIH | None | httpsreporternihgovquickSearchI01CX002516 |