Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia

Phase 1

Withdrawn

• Conditions: RSD (Reflex Sympathetic Dystrophy); Fibromyalgia; CRPS - Complex Regional Pain Syndrome Type I
• Interventions: Procedure: Lipoaspiration; Procedure: Normal Saline IV; Procedure: ADcSVF isolation

• Registration Number: NCT02987855
• Lead Sponsor: Healeon Medical Inc

Brief 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.

Study Timeline

• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-09
• Study Start: 2018-12-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-14
• Last Update Posted: 2021-02-16
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with confirmed diagnosis of RSD, CRPS, and severe Fibromyalgia
• Ability to provide Informed Consent (or as parent or legal guardian)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipoaspiration Arm 1	Lipoaspiration	Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe lipoaspiration harvest of subdermal fat
Normal Saline IV Arm 3	Normal Saline IV	Normal Saline IV with AD-cSVF cells
AD-cSVF Arm 2	ADcSVF isolation	ADcSVF Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction

Primary Outcome Measures

Name	Time	Method
Adverse and Severe Adverse Reaction Report	12 months	Evaluate any Adverse or Severe Adverse Reactions

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of Lifestyle	6 months, 12 months	Fibromyalgia Impact Questionnaire (FIQR)
Change in Quality of Life from Baseline	6 months, 12 months	Quality of Life Questionnaire (QoL)
Change from Baseline Pain Levels	1 month, 6 month, 1 year	Pain Scale Questionnaire 1-10

Trial Locations

Locations (2)

Regenevita LLC; 🇺🇸 Stevensville, Montana, United States

GARM; 🇭🇳 Roatan, Hn, Honduras