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

This study is currently recruiting participants.
Verified September 2017 by Robert W. Alexander, MD, FICS, Healeon Medical Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02987855
First Posted: December 9, 2016
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert W. Alexander, MD, FICS, Healeon Medical Inc
  Purpose

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.


Condition Intervention Phase
RSD (Reflex Sympathetic Dystrophy) CRPS - Complex Regional Pain Syndrome Type I Fibromyalgia Procedure: Lipoaspiration Procedure: ADcSVF isolation Procedure: Normal Saline IV Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), and Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Robert W. Alexander, MD, FICS, Healeon Medical Inc:

Primary Outcome Measures:
  • Adverse and Severe Adverse Reaction Report [ Time Frame: 12 months ]
    Evaluate any Adverse or Severe Adverse Reactions


Secondary Outcome Measures:
  • Change from Baseline Pain Levels [ Time Frame: 1 month, 6 month, 1 year ]
    Pain Scale Questionnaire 1-10

  • Change in Quality of Life from Baseline [ Time Frame: 6 months, 12 months ]
    Quality of Life Questionnaire (QoL)

  • Change from Baseline of Lifestyle [ Time Frame: 6 months, 12 months ]
    Fibromyalgia Impact Questionnaire (FIQR)


Estimated Enrollment: 100
Study Start Date: December 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987855


Contacts
Contact: Robert W Alexander, MD 406.777.5312 rwamd@cybernet1.com
Contact: Susan Riley, CMA 406.777.5312 irbtrials1@gmail.com

Locations
United States, Montana
Regenevita LLC Recruiting
Stevensville, Montana, United States, 59870
Contact: Susan Riley, CMA    406-777-5312    irbtrials1@gmail.com   
Contact: Nancy L Smith, MA,ORT    406777.5312    nancy@cybernet1.com   
Honduras
GARM Recruiting
Roatan, HN, Honduras
Contact: Glenn C Terry, MD    +1.765.669.9141    corky3444@gmail.com   
Contact: Heather Terry    17065669141    info@garm.com.hn   
Principal Investigator: Glenn C Terry, MD         
Principal Investigator: Robert W Alexander, MD         
Sponsors and Collaborators
Healeon Medical Inc
Investigators
Principal Investigator: Glenn C Terry, MD Global Alliance for Regenerative Medicine (GARM)
  More Information

Publications:

Responsible Party: Robert W. Alexander, MD, FICS, Principal Investigator, Science, Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT02987855     History of Changes
Other Study ID Numbers: RSD-CRPS
First Submitted: December 5, 2016
First Posted: December 9, 2016
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Fibromyalgia
Myofascial Pain Syndromes
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases