NCT02987855

Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia

Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), and Fibromyalgia

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Healeon Medical Inc · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Clinical Features include neurogenic inflammation, nociceptive sensitization, vasomotor dysfunction and maladaptive neuroplasticity. As these often seem related to specific injury sites (trauma, surgical, etc.) which are followed with severe pain sensations such as stabbing, burning, throbbing, and local muscular spasms or hemiparesis. In addition, there are many reports of visual change, dropping attacks (sudden falling), joint soreness, and other systemic symptoms associated with potentially any organ in the body. Diagnosis typically recognizes 3 distinct "types" which do not appear to be sequential in nature. Type 1 characterization is severe, burning sensory change near an injury site, musculoskeletal and joint stiffness. Type 2 demonstrates very high pain levels, swelling, muscular atrophy, joint degeneration, depression, and other concomitant dysfunctions. Type 3 features irreversible changes to skin/bone, and extreme loss of function of muscle (atrophic primarily) and tendons. A significant percentage (13-70 ) are felt to be at risk if neurological injuries, hemiplegia, enhanced vasomotor issues due to enhanced sympathetic actions and neurotransmission issues. This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.

Conditions

• RSD (Reflex Sympathetic Dystrophy)
• CRPS - Complex Regional Pain Syndrome Type I
• Fibromyalgia

Interventions

Type	Name	Description
PROCEDURE	Lipoaspiration	Closed syringe harvesting subdermal fat
PROCEDURE	ADcSVF isolation	Isolation of AD-cSVF from lipoaspirate via enzymatic digestion
PROCEDURE	Normal Saline IV	Normal Saline IV containing autologous AD-cSVF

Timeline

• Start date: 2018-12-15
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2016-12-09
• Last updated: 2021-02-16

Locations

2 sites across 2 countries: United States, Honduras