Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Fibromyalgia, Orthopedic, Pain, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 2/1/2019 |
| Start Date: | December 2016 |
| End Date: | June 2023 |
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.
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.
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.
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.
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
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