Clinical trial NCT02987855: Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia
Official title: Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), and Fibromyalgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: RSD (Reflex Sympathetic Dystrophy)
CRPS - Complex Regional Pain Syndrome Type I
Fibromyalgia
Lead sponsor: Healeon Medical Inc
Sponsor class: INDUSTRY
First posted: 2016-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Adverse and Severe Adverse Reaction Report
timeFrame: 12 months
Secondary outcomes:
measure: Change from Baseline Pain Levels
timeFrame: 1 month, 6 month, 1 year
measure: Change in Quality of Life from Baseline
timeFrame: 6 months, 12 months
measure: Change from Baseline of Lifestyle
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Stevensville
country: United States
facility: Regenevita LLC
state: Montana
city: Roatan
country: Honduras
facility: GARM
state: Hn
Study officials:
affiliation: Global Alliance for Regenerative Medicine (GARM)
name: Glenn C Terry, MD
role: PRINCIPAL_INVESTIGATOR
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