Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
Study NCT ID:
NCT02939859
Status:
WITHDRAWN
Last Update Posted:
2021-02-16
First Post:
2016-10-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoimmune, Inflammatory, Neurologic Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn \\[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\\]', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-14', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events [Time Frame: Outcome measures evaluated at baseline and reviewed at 6 month intervals for average time frame of 5 years]', 'timeFrame': '6 month intervals for up to 5 years', 'description': 'Activities of Daily Living (ADL)'}], 'secondaryOutcomes': [{'measure': 'Neurologic Functioning', 'timeFrame': '6 month intervals for up to 5 years', 'description': 'Deficits of neurologic function identified by patient as impaired prior to treatment assessed. Examples: neurologic function may include speech, balance, motor/sensory actions, hearing, gait, strength, pain, paresthesias'}, {'measure': 'Quality of Life Questionnairre', 'timeFrame': '1 year', 'description': 'Change from baseline in overall General Quality of Life (GQL) Health status questionnaire (SF-36)'}, {'measure': 'Fatigue', 'timeFrame': '6 month intervals for up to 5 years', 'description': 'Change from baseline measured by modified fatigue impact scale (MFIS)'}, {'measure': 'Cognitive Problems', 'timeFrame': '1 year intervals for up to 5 years', 'description': 'Cognitive Problems measured by Perceived Deficits Questionnaire (PDQ)'}, {'measure': 'Brain Lesions', 'timeFrame': '6 month intervals for up to 5 years', 'description': 'PIXYL Software Analysis from Baseline and at 6 month MRI with/without contrast Brain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Demyelinating Diseases', 'Nervous System Diseases', 'Autoimmune Disorders'], 'conditions': ['Multiple Sclerosis', 'Autoimmune']}, 'referencesModule': {'references': [{'pmid': '22189514', 'type': 'BACKGROUND', 'citation': 'Nakahara J, Maeda M, Aiso S, Suzuki N. Current concepts in multiple sclerosis: autoimmunity versus oligodendrogliopathy. Clin Rev Allergy Immunol. 2012 Feb;42(1):26-34. doi: 10.1007/s12016-011-8287-6.'}, {'pmid': '17444504', 'type': 'BACKGROUND', 'citation': 'Ascherio A, Munger KL. Environmental risk factors for multiple sclerosis. Part I: the role of infection. Ann Neurol. 2007 Apr;61(4):288-99. doi: 10.1002/ana.21117.'}, {'pmid': '22146321', 'type': 'BACKGROUND', 'citation': 'Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55.'}, {'pmid': '16420779', 'type': 'BACKGROUND', 'citation': 'Huntley A. A review of the evidence for efficacy of complementary and alternative medicines in MS. Int MS J. 2006 Jan;13(1):5-12, 4.'}, {'pmid': '8017890', 'type': 'BACKGROUND', 'citation': 'Weinshenker BG. Natural history of multiple sclerosis. Ann Neurol. 1994;36 Suppl:S6-11. doi: 10.1002/ana.410360704.'}, {'pmid': '14747002', 'type': 'BACKGROUND', 'citation': 'Dyment DA, Ebers GC, Sadovnick AD. Genetics of multiple sclerosis. Lancet Neurol. 2004 Feb;3(2):104-10. doi: 10.1016/s1474-4422(03)00663-x.'}, {'pmid': '22041658', 'type': 'BACKGROUND', 'citation': 'Hassan-Smith G, Douglas MR. Epidemiology and diagnosis of multiple sclerosis. Br J Hosp Med (Lond). 2011 Oct;72(10):M146-51. doi: 10.12968/hmed.2011.72.sup10.m146.'}, {'pmid': '24871874', 'type': 'BACKGROUND', 'citation': "Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28."}, {'pmid': '23235682', 'type': 'BACKGROUND', 'citation': 'He D, Xu Z, Dong S, Zhang H, Zhou H, Wang L, Zhang S. Teriflunomide for multiple sclerosis. Cochrane Database Syst Rev. 2012 Dec 12;12:CD009882. doi: 10.1002/14651858.CD009882.pub2.'}, {'pmid': '22782520', 'type': 'BACKGROUND', 'citation': 'Manouchehrinia A, Constantinescu CS. Cost-effectiveness of disease-modifying therapies in multiple sclerosis. Curr Neurol Neurosci Rep. 2012 Oct;12(5):592-600. doi: 10.1007/s11910-012-0291-6.'}, {'pmid': '22082979', 'type': 'BACKGROUND', 'citation': 'Hassan-Smith G, Douglas MR. Management and prognosis of multiple sclerosis. Br J Hosp Med (Lond). 2011 Nov;72(11):M174-6. doi: 10.12968/hmed.2011.72.sup11.m174.'}, {'pmid': '21205679', 'type': 'BACKGROUND', 'citation': 'Freedman MS. Long-term follow-up of clinical trials of multiple sclerosis therapies. Neurology. 2011 Jan 4;76(1 Suppl 1):S26-34. doi: 10.1212/WNL.0b013e318205051d.'}, {'pmid': '21205678', 'type': 'BACKGROUND', 'citation': 'Bates D. Treatment effects of immunomodulatory therapies at different stages of multiple sclerosis in short-term trials. Neurology. 2011 Jan 4;76(1 Suppl 1):S14-25. doi: 10.1212/WNL.0b013e3182050388.'}, {'pmid': '23728638', 'type': 'BACKGROUND', 'citation': 'Martinelli Boneschi F, Vacchi L, Rovaris M, Capra R, Comi G. Mitoxantrone for multiple sclerosis. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD002127. doi: 10.1002/14651858.CD002127.pub3.'}, {'pmid': '22371220', 'type': 'BACKGROUND', 'citation': 'Balak DM, Hengstman GJ, Cakmak A, Thio HB. Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review. Mult Scler. 2012 Dec;18(12):1705-17. doi: 10.1177/1352458512438239. Epub 2012 Feb 27.'}, {'pmid': '19882365', 'type': 'BACKGROUND', 'citation': 'Comi G. Treatment of multiple sclerosis: role of natalizumab. Neurol Sci. 2009 Oct;30 Suppl 2:S155-8. doi: 10.1007/s10072-009-0147-2.'}, {'pmid': '23235605', 'type': 'BACKGROUND', 'citation': 'Farinotti M, Vacchi L, Simi S, Di Pietrantonj C, Brait L, Filippini G. Dietary interventions for multiple sclerosis. Cochrane Database Syst Rev. 2012 Dec 12;12:CD004192. doi: 10.1002/14651858.CD004192.pub3.'}, {'pmid': '19222053', 'type': 'BACKGROUND', 'citation': 'Olsen SA. A review of complementary and alternative medicine (CAM) by people with multiple sclerosis. Occup Ther Int. 2009;16(1):57-70. doi: 10.1002/oti.266.'}, {'pmid': '21425270', 'type': 'BACKGROUND', 'citation': 'Miller AE. Multiple sclerosis: where will we be in 2020? Mt Sinai J Med. 2011 Mar-Apr;78(2):268-79. doi: 10.1002/msj.20242.'}, {'pmid': '23039386', 'type': 'BACKGROUND', 'citation': 'Luessi F, Siffrin V, Zipp F. Neurodegeneration in multiple sclerosis: novel treatment strategies. Expert Rev Neurother. 2012 Sep;12(9):1061-76; quiz 1077. doi: 10.1586/ern.12.59.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via intravascular system of quality of life and alteration of documented Muscular Sclerosis (MS) and related neurodegenerative patients. It is believed that the heterogeneous cell population which includes multipotent stem/stromal cells are capable of immune modulation/inflammatory modulation properties. Exam of disease progression and quality of life changes will be evaluated.', 'detailedDescription': 'Multiple Sclerosis (MS) is a demyelination disease which features damage to insulating covers of nerve cells in the brain and spinal cord. This damage or degenerative changes disrupts the ability of parts of the nervous system to communicate, resulting in range of signs and symptoms which include physical and mental changes.\n\nSymptoms are variable and often include visual changes, sensory irregularities, and motor coordination. MS has several forms which result in new symptoms in either isolated attacks (relapsing forms) or gradual increasing symptoms (progressive forms).\n\nWhile cause is not clear, mechanisms have been suggested association with loss of the immune system or failure to produce myelin-producing cells. Some suggest a genetic predisposition or environmental factor, but the exact causation in all cases have not been elucidated.\n\nMedications have been developed, but remain modestly effective and possessing major side effects and poorly tolerated. Alternative treatments, including physical therapy and some stem/stromal therapies have become more common.\n\nThree main characteristics of MS are: 1). Lesion formations in the central nervous system (called Plaques); 2). Inflammation; 3). Destruction of myelin sheaths of neurons. This demyelination is thought to stimulate the inflammatory processes due to action of a lymphocyte group known at T-cell which seems to recognize patient\'s own myelin as foreign and proceeds to attack it (known as "autoreactive lymphocytes").\n\nTraditionally, exacerbation\'s are often treated with high dose intravenous steroids which may be of short term reduction of symptoms, not addressing the underlying causation. Current medications available for treatment are expensive and fraught with major side effects, making their use very difficult and producing limited measured value.\n\nWith the advent of convenient adipose harvesting and processing in closed systems, the ability to easily and safely acquire significant of stem/stromal cells, studies are underway to utilize autologous stem/stromal cells. This study is aimed at evaluation of the safety profile (adverse reactions \\& severe adverse reaction) of the closed syringe, microcannula harvesting of subdermal fat deposits. This autologous cell group obtained with isolation and concentration of cells within the stromal vascular fraction (SVF) via enzymatic digestion, and deployed via intravascular routes. As these cells are very small, there is belief that they are able to pass into the cerebral fluids in defects of the blood brain barrier (BBB) or are small enough to pass into the fluids of the CNS (central nervous system).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented functional damage to central or peripheral nervous system unlikely to improve with present standard of care\n* At least 6 months after onset of disease process\n* If under current medical therapy (drug or surgical) for the condition, patient considered stable on that treatment and unlikely to have significant reversal of associated neurological functions damage as a result of ongoing treatments\n* In estimation of providers and neurologists have the potential for improvement with AD-cSVF treatment, and be at minimal risk of potential harm from the procedure\n* Over 18 year old, and capable of providing informed consent\n* Medically stable and cleared by primary care physician, neurologist, or licensed practitioner that patient is felt to be reasonably expected to be expected to undergo procedures without known significant risk to health\n\nExclusion Criteria:\n\n* Patient must be capable of an adequate neurologic examination and evaluation to document the pathology and ability to cooperate with examination\n* Patient much be capable and willing to undergo follow up neurologic exams with investigators or their own neurologists\n* Patient must be capable and competent to provide informed consent to participation\n* In estimation of investigators, the patient may be at increased or significant risk of harm to the patient's general health or neurologic functions for collection of AD-cSVF collection\n* Patients not medically stable, or who may be at significant risk to their health undergoing any and all procedures will not be eligible\n* Women of childbearing age must not be pregnant at the time of treatment, and should refrain from becoming pregnant for 3 months post-treatment"}, 'identificationModule': {'nctId': 'NCT02939859', 'acronym': 'cSVF', 'briefTitle': 'Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoimmune, Inflammatory, Neurologic Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healeon Medical Inc'}, 'officialTitle': 'Use of Cellular Stromal Vascular Fraction (cSVF) for Select Multiple Sclerosis, Autoimmune, Inflammatory, and Neurologic Conditions: Clinical Interventional Study of Adverse Events and Clinical Outcomes Using Autologous Stem-Stromal Cells.', 'orgStudyIdInfo': {'id': 'RGV-GARM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microcannula Harvest Adipose', 'description': 'Acquisition AD-tSVF via closed syringe microcannula', 'interventionNames': ['Procedure: Microcannula Harvest Adipose']}, {'type': 'EXPERIMENTAL', 'label': 'Centricyte 1000', 'description': 'Autologous Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF', 'interventionNames': ['Device: Centricyte 1000']}, {'type': 'EXPERIMENTAL', 'label': 'Sterile Normal Saline', 'description': 'Re-suspension of Autologous AD-cSVF pellet in Normal Saline deployment via IV', 'interventionNames': ['Procedure: Sterile Normal Saline IV deployment AD-cSVF']}], 'interventions': [{'name': 'Microcannula Harvest Adipose', 'type': 'PROCEDURE', 'description': 'Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells', 'armGroupLabels': ['Microcannula Harvest Adipose']}, {'name': 'Centricyte 1000', 'type': 'DEVICE', 'description': 'Use of Centricyte 1000 closed system digestion adipose tissue stromal vascular fraction to create a AD-cSVF', 'armGroupLabels': ['Centricyte 1000']}, {'name': 'Sterile Normal Saline IV deployment AD-cSVF', 'type': 'PROCEDURE', 'description': 'Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use', 'armGroupLabels': ['Sterile Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59870', 'city': 'Stevensville', 'state': 'Montana', 'country': 'United States', 'facility': 'Regenevita LLC', 'geoPoint': {'lat': 46.50992, 'lon': -114.09316}}, {'city': 'Roatán', 'state': 'Hn', 'country': 'Honduras', 'facility': 'Global Alliance for Regenerative Medicine (GARM)', 'geoPoint': {'lat': 16.3229, 'lon': -86.53605}}], 'overallOfficials': [{'name': 'Robert W Alexander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GARM International'}, {'name': 'Glenn C Terry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GARM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Annual Summary of Cases to All Collaborators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healeon Medical Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Global Alliance for Regenerative Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Science', 'investigatorFullName': 'Robert W. Alexander, MD, FICS', 'investigatorAffiliation': 'Healeon Medical Inc'}}}}