Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia (ADcSVF-CRPS)

February 14, 2021 updated by: Robert W. Alexander, MD, FICS, Healeon Medical Inc

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Honduras
    • Hn
      • Roatan, Hn, Honduras
        • GARM
  • United States
    • Montana
      • Stevensville, Montana, United States, 59870
        • Regenevita LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipoaspiration Arm 1
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe lipoaspiration harvest of subdermal fat
Procedure: Lipoaspiration
Closed syringe harvesting subdermal fat
Experimental: AD-cSVF Arm 2
ADcSVF Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction
Procedure: ADcSVF isolation
Isolation of AD-cSVF from lipoaspirate via enzymatic digestion
Experimental: Normal Saline IV Arm 3
Normal Saline IV with AD-cSVF cells
Procedure: Normal Saline IV
Normal Saline IV containing autologous AD-cSVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse and Severe Adverse Reaction Report
Time Frame: 12 months
Evaluate any Adverse or Severe Adverse Reactions
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healeon Medical Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 14, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSD-CRPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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