Study Results
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Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2018-12-15
2024-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lipoaspiration Arm 1
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe lipoaspiration harvest of subdermal fat
Lipoaspiration
Closed syringe harvesting subdermal fat
AD-cSVF Arm 2
ADcSVF Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction
ADcSVF isolation
Isolation of AD-cSVF from lipoaspirate via enzymatic digestion
Normal Saline IV Arm 3
Normal Saline IV with AD-cSVF cells
Normal Saline IV
Normal Saline IV containing autologous AD-cSVF
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Ability to provide Informed Consent (or as parent or legal guardian)
Exclusion Criteria
* Patients with documented Opiate abuse
* Patient taking corticosteroid therapy, immune suppression, or chemotherapeutic regimen within 6 months of entry
16 Years
ALL
No
Sponsors
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Healeon Medical Inc
INDUSTRY
Responsible Party
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Robert W. Alexander, MD, FICS
Principal Investigator, Science
Principal Investigators
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Glenn C Terry, MD
Role: PRINCIPAL_INVESTIGATOR
Global Alliance for Regenerative Medicine (GARM)
Locations
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Regenevita LLC
Stevensville, Montana, United States
GARM
Roatán, Hn, Honduras
Countries
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References
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Schwartzman RJ, Erwin KL, Alexander GM. The natural history of complex regional pain syndrome. Clin J Pain. 2009 May;25(4):273-80. doi: 10.1097/AJP.0b013e31818ecea5.
Marinus J, Moseley GL, Birklein F, Baron R, Maihofner 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.
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.
Maihofner C, Forster C, Birklein F, Neundorfer B, Handwerker HO. Brain processing during mechanical hyperalgesia in complex regional pain syndrome: a functional MRI study. Pain. 2005 Mar;114(1-2):93-103. doi: 10.1016/j.pain.2004.12.001. Epub 2005 Jan 26.
Watkins LR, Maier SF. Immune regulation of central nervous system functions: from sickness responses to pathological pain. J Intern Med. 2005 Feb;257(2):139-55. doi: 10.1111/j.1365-2796.2004.01443.x.
Birklein F. Complex regional pain syndrome. J Neurol. 2005 Feb;252(2):131-8. doi: 10.1007/s00415-005-0737-8.
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.
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.
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.
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.
Azari P, Lindsay DR, Briones D, Clarke C, Buchheit T, Pyati S. Efficacy and safety of ketamine in patients with complex regional pain syndrome: a systematic review. CNS Drugs. 2012 Mar 1;26(3):215-28. doi: 10.2165/11595200-000000000-00000.
Opal SM, Wiest PM, Olds GR. Traveler's diarrhea: methods of prevention and treatment. R I Med J (1976). 1990 May;73(5):199-204.
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.
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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Other Identifiers
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RSD-CRPS
Identifier Type: -
Identifier Source: org_study_id
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