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Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia

NCT02987855 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-02-16

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Healeon Medical Inc

    lead INDUSTRY

Principal Investigators

  • Glenn C Terry, MD · Global Alliance for Regenerative Medicine (GARM)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • United States
  • Honduras

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02987855 on ClinicalTrials.gov