Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: RSD (Reflex Sympathetic Dystrophy), CRPS - Complex Regional Pain Syndrome Type I, Fibromyalgia
In brief
Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and Fibromyalgia represent progressive systemic pain conditions which often worsen over time. They appear to be dysregulation of the central nervous system (CNS) and the autonomic system (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and disabilities. They are often associated with injury sites (including surgical) which produce constant, often disabling pain and motor-sensory losses. Treatments are often ineffective and include medications (often high dose opiates), Physical Therapy (PT), and surgical interventions (sympathectomy, ablation) or insertion stimulators of the CNS. Study is an interventional study to document the safety and efficacy of use of adipose-derived cellular stromal vascular fraction (AD-cSVF) in chronic pain and dysfunction disease groups.
Key facts
- Study ID
- NCT02987855
- Run by
- Healeon Medical Inc
- People needed
- 0
- Starts
- 2018-12-15
- Expected to finish
- 2024-06-01
- Last updated by the study team
- 2021-02-16
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with confirmed diagnosis of RSD, CRPS, and severe Fibromyalgia
- Ability to provide Informed Consent (or as parent or legal guardian)
You may not qualify if…
- Patients with severe comorbidities which, in opinion of PI or provider associates. would be unsafe or not advised to be able to comply with study or follow up requirements
- Patients with documented Opiate abuse
- Patient taking corticosteroid therapy, immune suppression, or chemotherapeutic regimen within 6 months of entry
Where it is running
- Regenevita LLC — Stevensville, Montana, United States
- GARM — Roatán, Hn, Honduras
Full record on ClinicalTrials.gov
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