Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia

Fibromyalgia Clinical Trial

— ADcSVF-CRPS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02987855
• Other study ID #: RSD-CRPS
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: December 15, 2018
• Est. completion date: June 2024

Study information

• Verified date: February 2021
• Source: Healeon Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• CRPS - Complex Regional Pain Syndrome Type I
• Fibromyalgia
• Myofascial Pain Syndromes
• Reflex Sympathetic Dystrophy
• RSD (Reflex Sympathetic Dystrophy)
• Syndrome

Intervention

Procedure:
• Lipoaspiration
Closed syringe harvesting subdermal fat
• ADcSVF isolation
Isolation of AD-cSVF from lipoaspirate via enzymatic digestion
• Normal Saline IV
Normal Saline IV containing autologous AD-cSVF

Locations

Country	Name	City	State
Honduras	GARM	Roatan	Hn
United States	Regenevita LLC	Stevensville	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Healeon Medical Inc

Countries where clinical trial is conducted

United States,  Honduras, 

References & Publications (15)

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Birklein F. Complex regional pain syndrome. J Neurol. 2005 Feb;252(2):131-8. Review. — View Citation

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. — View Citation

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Marinus J, Moseley GL, Birklein F, Baron R, Maihöfner C, Kingery WS, van Hilten JJ. Clinical features and pathophysiology of complex regional pain syndrome. Lancet Neurol. 2011 Jul;10(7):637-48. doi: 10.1016/S1474-4422(11)70106-5. Review. — View Citation

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Swart CM, Stins JF, Beek PJ. Cortical changes in complex regional pain syndrome (CRPS). Eur J Pain. 2009 Oct;13(9):902-7. doi: 10.1016/j.ejpain.2008.11.010. Epub 2008 Dec 19. Review. — View Citation

van de Meent H, Oerlemans M, Bruggeman A, Klomp F, van Dongen R, Oostendorp R, Frölke 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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse and Severe Adverse Reaction Report	Evaluate any Adverse or Severe Adverse Reactions	12 months
Secondary	Change from Baseline Pain Levels	Pain Scale Questionnaire 1-10	1 month, 6 month, 1 year
Secondary	Change in Quality of Life from Baseline	Quality of Life Questionnaire (QoL)	6 months, 12 months
Secondary	Change from Baseline of Lifestyle	Fibromyalgia Impact Questionnaire (FIQR)	6 months, 12 months