Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-17 @ 4:45 PM
Study NCT ID:
NCT02959294
Status:
WITHDRAWN
Last Update Posted:
2021-02-16
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': '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Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\\]\\]', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-14', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Outcome measures at baseline at 6 month', 'description': 'Activities of Daily Living (ADL)'}, {'measure': 'Cognitive Change in clinical symptoms associated with concussion-TBI', 'timeFrame': 'Outcome measures at baseline and reviewed 1 year interval for average time 5 years', 'description': 'Montreal Cognitive Assessment Scale (MCAS)'}], 'secondaryOutcomes': [{'measure': "Beck's Depression Inventory (BDI)", 'timeFrame': 'Annual for 5 years', 'description': 'Multiple choice self reporting measure of depression'}, {'measure': 'Adult Attention Deficit Assessment', 'timeFrame': 'Annual for 5 years', 'description': "Conner's Adult Attention Deficit Disorder Rate Scale (CAADDR)"}, {'measure': 'MRI Brain With & MRI Brain With & Without Contrast', 'timeFrame': '0, 3 years, 5 years', 'description': 'MRI Brain to evaluate progressive changes comparing pre-treatment (0), 3 year and 5 year status'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TBI', 'mTBI', 'Concussion, Brain', 'Loss Consciousness, Traumatic', 'Headaches'], 'conditions': ['Traumatic Encephalopathies, Chronic', 'Concussion, Mild', 'Concussion, Intermediate', 'Concussion, Severe', 'Concussion, Brain']}, 'referencesModule': {'references': [{'pmid': '18635021', 'type': 'BACKGROUND', 'citation': 'Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.'}, {'pmid': '17622833', 'type': 'BACKGROUND', 'citation': 'Parikh S, Koch M, Narayan RK. Traumatic brain injury. Int Anesthesiol Clin. 2007 Summer;45(3):119-35. doi: 10.1097/AIA.0b013e318078cfe7. No abstract available.'}, {'pmid': '18627252', 'type': 'BACKGROUND', 'citation': 'Saatman KE, Duhaime AC, Bullock R, Maas AI, Valadka A, Manley GT; Workshop Scientific Team and Advisory Panel Members. Classification of traumatic brain injury for targeted therapies. J Neurotrauma. 2008 Jul;25(7):719-38. doi: 10.1089/neu.2008.0586.'}, {'pmid': '19196176', 'type': 'BACKGROUND', 'citation': 'Kumar R, Husain M, Gupta RK, Hasan KM, Haris M, Agarwal AK, Pandey CM, Narayana PA. Serial changes in the white matter diffusion tensor imaging metrics in moderate traumatic brain injury and correlation with neuro-cognitive function. J Neurotrauma. 2009 Apr;26(4):481-95. doi: 10.1089/neu.2008.0461.'}, {'pmid': '17112190', 'type': 'BACKGROUND', 'citation': "Pellman EJ, Viano DC; National Football League's Committee on Mild Traumatic Brain Injury. Concussion in professional football: summary of the research conducted by the National Football League's Committee on Mild Traumatic Brain Injury. Neurosurg Focus. 2006 Oct 15;21(4):E12. doi: 10.3171/foc.2006.21.4.13."}, {'pmid': '17826211', 'type': 'BACKGROUND', 'citation': 'Heegaard W, Biros M. Traumatic brain injury. Emerg Med Clin North Am. 2007 Aug;25(3):655-78, viii. doi: 10.1016/j.emc.2007.07.001.'}, {'pmid': '18057896', 'type': 'BACKGROUND', 'citation': 'Pearce JM. Observations on concussion. A review. Eur Neurol. 2008;59(3-4):113-9. doi: 10.1159/000111872. Epub 2007 Nov 30.'}, {'pmid': '16286874', 'type': 'BACKGROUND', 'citation': 'Concussion (mild traumatic brain injury) and the team physician: a consensus statement. Med Sci Sports Exerc. 2005 Nov;37(11):2012-6. doi: 10.1249/01.mss.0000186726.18341.70. No abstract available.'}, {'pmid': '15883140', 'type': 'BACKGROUND', 'citation': 'Hall RC, Hall RC, Chapman MJ. Definition, diagnosis, and forensic implications of postconcussional syndrome. Psychosomatics. 2005 May-Jun;46(3):195-202. doi: 10.1176/appi.psy.46.3.195.'}, {'pmid': '10981754', 'type': 'BACKGROUND', 'citation': 'Maroon JC, Lovell MR, Norwig J, Podell K, Powell JW, Hartl R. Cerebral concussion in athletes: evaluation and neuropsychological testing. Neurosurgery. 2000 Sep;47(3):659-69; discussion 669-72. doi: 10.1097/00006123-200009000-00027.'}, {'pmid': '21228656', 'type': 'BACKGROUND', 'citation': 'Randolph C. Baseline neuropsychological testing in managing sport-related concussion: does it modify risk? Curr Sports Med Rep. 2011 Jan-Feb;10(1):21-6. doi: 10.1249/JSR.0b013e318207831d.'}, {'pmid': '3091631', 'type': 'BACKGROUND', 'citation': 'Binder LM. Persisting symptoms after mild head injury: a review of the postconcussive syndrome. J Clin Exp Neuropsychol. 1986 Aug;8(4):323-46. doi: 10.1080/01688638608401325.'}, {'pmid': '18551365', 'type': 'BACKGROUND', 'citation': 'Thornton KE, Carmody DP. Efficacy of traumatic brain injury rehabilitation: interventions of QEEG-guided biofeedback, computers, strategies, and medications. Appl Psychophysiol Biofeedback. 2008 Jun;33(2):101-24. doi: 10.1007/s10484-008-9056-z. Epub 2008 Jun 13.'}, {'pmid': '7617178', 'type': 'BACKGROUND', 'citation': 'Alexander MP. Mild traumatic brain injury: pathophysiology, natural history, and clinical management. Neurology. 1995 Jul;45(7):1253-60. doi: 10.1212/wnl.45.7.1253. No abstract available.'}, {'pmid': '19176544', 'type': 'BACKGROUND', 'citation': 'De Beaumont L, Theoret H, Mongeon D, Messier J, Leclerc S, Tremblay S, Ellemberg D, Lassonde M. Brain function decline in healthy retired athletes who sustained their last sports concussion in early adulthood. Brain. 2009 Mar;132(Pt 3):695-708. doi: 10.1093/brain/awn347. Epub 2009 Jan 28.'}, {'pmid': '17762733', 'type': 'BACKGROUND', 'citation': 'Cantu RC. Chronic traumatic encephalopathy in the National Football League. Neurosurgery. 2007 Aug;61(2):223-5. doi: 10.1227/01.NEU.0000255514.73967.90. No abstract available.'}, {'pmid': '10946737', 'type': 'BACKGROUND', 'citation': 'Jordan BD. Chronic traumatic brain injury associated with boxing. Semin Neurol. 2000;20(2):179-85. doi: 10.1055/s-2000-9826.'}, {'pmid': '16983222', 'type': 'BACKGROUND', 'citation': 'Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.'}, {'pmid': '9475969', 'type': 'BACKGROUND', 'citation': 'Cantu RC. Second-impact syndrome. Clin Sports Med. 1998 Jan;17(1):37-44. doi: 10.1016/s0278-5919(05)70059-4.'}, {'pmid': '15083872', 'type': 'BACKGROUND', 'citation': 'Borg J, Holm L, Peloso PM, Cassidy JD, Carroll LJ, von Holst H, Paniak C, Yates D; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Non-surgical intervention and cost for mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med. 2004 Feb;(43 Suppl):76-83. doi: 10.1080/16501960410023840.'}]}, 'descriptionModule': {'briefSummary': 'Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function following concussion, particularly in contact, repetitive sports injuries. Range of damage is measured in Grade I-III according to graduated severity. Unfortunately, less information is available about repetitive concussions and the long-term health issues.', 'detailedDescription': "Concussion Syndrome (CS) and TBI are common injuries producing temporary and long-term damage to impact brain function. Symptoms are sometimes transient, sometimes long-term depending on severity and/or repetitive damage. Signs varying from recurrent headaches, mental fog, emotional changes to physical signs of loss of consciousness, amnesia to behavioral change (irritability, loss of concentration ability, etc.), cognitive impairment (slow reaction times, memory loss), and recurring sleep disturbances.\n\nCommon causes include sports injuries, automobile accidents, falls, blunt trauma to head, and explosive/blast injuries from production of acceleration injuries\n\nTreatment often involves monitoring, physical rest, limiting cognitive activities (such as computing, video games, texting, and studying). Most often a single episode usually resolve or improve (particularly in recurring headaches) within 3-4 weeks. It is estimated that \\>6/1000 occurrence rate apply. Repetitive injuries seem to make the person more susceptible to additional damage, particularly with injury precedes resolution of an earlier damage. There appears also to make persons to require a lesser impact to produce the same degree of severity. It is becoming more recognized that repeated concussions increase the risks in later life for dementia, Parkinson's and severe depressions.\n\nMost serious signs to evaluate are loss of consciousness, seizures, worsening headache, diplopia/pupil changes, loss of recognition, vomiting, focal neurological problems, and change of personality.\n\nThere is no consensus definition of concussion or TBI. Most concussions are considered in the mild TBI (mTBI) group, and are rarely demonstrate structural brain damage when in the acute to subacute state. Late brain MRI changes are difficult to clearly point to or identify the specific areas of presumed damage.\n\nThis study is intended to examine safety and efficacy of parenteral introduction of AD-cSVF in cases of CS and TBI, and categorically examine the outcomes according to the elapsed time from original concussive event. No delineation of those having recurrent damage and injuries are made within this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented history of mTBI or TBI with Correlated MRI or CT\n* At least 1 month post mTBI and TBI\n* Able and Willing to participate in CT or MRI pre-study and at 3 year, 5 year interval\n* Able to provide informed consent to undergo the study\n* Depression, Cognitive Disability, Attention Disorders, Headaches or other persistent changes which followed a traumatic brain event (TBI)\n* Impaired social or occupational functioning following mTBI or TBI\n* History of repetitive events for mTBI and TBI\n\nExclusion Criteria:\n\n* Documented history of neuro-degenerative illness, seizures, mental illness, or severe medical conditions preceding mTBI or TBI\n* Malignances, Bleeding Disorders, Pregnancy or Lactation\n* Tumors of Central Nervous System (CNS)\n* Lack of adequate donor tissue volume as determined by the primary investigator at their discretion\n* Any pre-existing medical condition which, in view of the primary investigator and patient's primary care physician, would prevent participation in study"}, 'identificationModule': {'nctId': 'NCT02959294', 'acronym': 'C-TBI', 'briefTitle': 'Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healeon Medical Inc'}, 'officialTitle': 'Use of Adipose-Derived Cellular Stromal Vascular Fraction (AD-cSVF) Parenterally in Post-Concussion Injuries and Traumatic Brain Injuries (TBI)', 'orgStudyIdInfo': {'id': 'RGV GARM 5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microcannula Harvest Adipose', 'description': 'Acquisition Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via close syringe microcannula harvest from subdermal fat deposits', 'interventionNames': ['Procedure: Microcannula Harvest Adipose']}, {'type': 'EXPERIMENTAL', 'label': 'Centricyte 1000', 'description': 'Autologous 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 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 Autologous AD-tSVF to create 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}}], 'overallOfficials': [{'name': 'Robert W. Alexander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GARM International and GARM USA'}, {'name': 'Glenn C Terry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GARM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Annual Summary of Case to All Collaborators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert W. Alexander, MD, FICS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert W. Alexander, MD, FICS', 'investigatorAffiliation': 'Healeon Medical Inc'}}}}