Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia

NCT02987855 | Withdrawn Phase 1 DMC

• 1 other identifier: RSD-CRPS
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Adverse and Severe Adverse Reaction Report

  Evaluate any Adverse or Severe Adverse Reactions

  12 months

Secondary Outcomes (3)

• Change from Baseline Pain Levels

  1 month, 6 month, 1 year

• Change in Quality of Life from Baseline

  6 months, 12 months

• Change from Baseline of Lifestyle

  6 months, 12 months

Study Arms (3)

Lipoaspiration Arm 1

EXPERIMENTAL

Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe lipoaspiration harvest of subdermal fat

Procedure: Lipoaspiration

AD-cSVF Arm 2

EXPERIMENTAL

ADcSVF Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction

Procedure: ADcSVF isolation

Normal Saline IV Arm 3

EXPERIMENTAL

Normal Saline IV with AD-cSVF cells

Procedure: Normal Saline IV

Interventions

Lipoaspiration PROCEDURE

Closed syringe harvesting subdermal fat

Lipoaspiration Arm 1

ADcSVF isolation PROCEDURE

Isolation of AD-cSVF from lipoaspirate via enzymatic digestion

AD-cSVF Arm 2

Normal Saline IV PROCEDURE

Normal Saline IV containing autologous AD-cSVF

Normal Saline IV Arm 3

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Healeon Medical Inc: lead

Study Sites (2)

Regenevita LLC

Stevensville, Montana, 59870, United States

Location

GARM

Roatán, Hn, Honduras

Location

Related Publications (15)

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• Veldman PH, Reynen HM, Arntz IE, Goris RJ. Signs and symptoms of reflex sympathetic dystrophy: prospective study of 829 patients. Lancet. 1993 Oct 23;342(8878):1012-6. doi: 10.1016/0140-6736(93)92877-v.

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• Lee BH, Scharff L, Sethna NF, McCarthy CF, Scott-Sutherland J, Shea AM, Sullivan P, Meier P, Zurakowski D, Masek BJ, Berde CB. Physical therapy and cognitive-behavioral treatment for complex regional pain syndromes. J Pediatr. 2002 Jul;141(1):135-40. doi: 10.1067/mpd.2002.124380.

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• van de Meent H, Oerlemans M, Bruggeman A, Klomp F, van Dongen R, Oostendorp R, Frolke JP. Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1. Pain. 2011 Jun;152(6):1431-1438. doi: 10.1016/j.pain.2011.02.032. Epub 2011 Apr 6.

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• Chopra P, Cooper MS. Treatment of Complex Regional Pain Syndrome (CRPS) using low dose naltrexone (LDN). J Neuroimmune Pharmacol. 2013 Jun;8(3):470-6. doi: 10.1007/s11481-013-9451-y. Epub 2013 Apr 2.

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• Varenna M, Adami S, Rossini M, Gatti D, Idolazzi L, Zucchi F, Malavolta N, Sinigaglia L. Treatment of complex regional pain syndrome type I with neridronate: a randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2013 Mar;52(3):534-42. doi: 10.1093/rheumatology/kes312. Epub 2012 Nov 30.

  PMID: 23204550 BACKGROUND

• Gainer MJ. Hypnotherapy for reflex sympathetic dystrophy. Am J Clin Hypn. 1992 Apr;34(4):227-32. doi: 10.1080/00029157.1992.10402852.

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MeSH Terms

Conditions

Complex Regional Pain Syndromes; Fibromyalgia

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Glenn C Terry, MD

  Global Alliance for Regenerative Medicine (GARM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Science

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 9, 2016
• Study Start: December 15, 2018
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); HO (1)