Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT03005418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2016-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-03-28', 'mcpReleaseN': 16, 'releaseDate': '2025-03-12'}, {'resetDate': '2025-04-25', 'mcpReleaseN': 17, 'releaseDate': '2025-04-09'}], 'estimatedResultsFirstSubmitDate': '2025-03-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D057772', 'term': 'Vascular System Injuries'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2016-12-23', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HAV primary patency', 'timeFrame': '30 days', 'description': "Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions"}, {'measure': 'Frequency and Severity of Adverse Events', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Limb viability (avoidance of amputation; limb cohort only)', 'timeFrame': '36 months'}, {'measure': 'HAV primary patency', 'timeFrame': '36 months', 'description': "Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions"}, {'measure': 'HAV primary assisted patency', 'timeFrame': '36 months', 'description': "Primary assisted patency is defined as 'the interval from the time of access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of patent access' i.e., patent without an intervention to clear a thrombus"}, {'measure': 'HAV secondary patency', 'timeFrame': '36 months', 'description': "Secondary patency is defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions"}, {'measure': 'Rate of HAV interventions', 'timeFrame': '36 months'}, {'measure': 'Patient survival', 'timeFrame': '36 months'}, {'measure': 'HAV remodeling as shown by histopathology of any clinical explants', 'timeFrame': '36 months'}, {'measure': 'Frequency of anastomotic bleeding or spontaneous rupture', 'timeFrame': '36 months'}, {'measure': 'Frequency of HAV infection', 'timeFrame': '36 months'}, {'measure': 'Frequency of HAV thrombosis', 'timeFrame': '36 months'}, {'measure': 'Frequency of HAV pseudoaneursym formation', 'timeFrame': '36 months'}, {'measure': 'Frequency of HAV aneursym formation', 'timeFrame': '36 months'}, {'measure': 'Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)', 'timeFrame': '36 months'}, {'measure': 'Frequency of HAV removal', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma', 'Vascular System Injury']}, 'referencesModule': {'references': [{'pmid': '41140335', 'type': 'DERIVED', 'citation': 'Lum Y, Moore EE, Kundi R, Morrison J, Shores JT, Niklason LE, Parikh S. Bioengineered human blood vessels to treat hospital-acquired vascular complications. J Vasc Surg Cases Innov Tech. 2025 Sep 8;11(6):101976. doi: 10.1016/j.jvscit.2025.101976. eCollection 2025 Dec.'}, {'pmid': '39565635', 'type': 'DERIVED', 'citation': 'Moore EE, Curi M, Namias N, Kundi R, Lum YW, Fox CJ, Rajani RR, Rasmussen TE, Sokolov O, Niklason LE, Khondker Z, Parikh SJ; CLN-PRO-V005 Investigators and the CLN-PRO-V017 Investigators. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. 2025 Feb 1;160(2):181-189. doi: 10.1001/jamasurg.2024.4893.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.', 'detailedDescription': 'This is a prospective, multicenter, multi cohort, non-randomized phase 2 study in up to 40 adult patients with life or limb threatening vascular trauma which requires surgical repair. There will be a limb cohort and a torso cohort. The limb cohort will include patients who require repair of a vessel contained to the upper or lower extremity. The torso cohort includes patients who require repair of vessels within the thorax (excluding the heart), abdomen, and retroperitoneum. Subjects will be implanted with a Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.\n\nThe active study duration for each study participant will be 36 months from HAV implantation or until HAV failure/ removal/ death if earlier. Follow up after month 12 will involve the capture of information on assessments performed at "standard of care" routine clinic visits or by telephone follow up with the patient or his/her physician with physical exam and ultrasound at month 24 and month 36\n\nThe total expected duration of the clinical study is 61 months (24 months of enrollment and 36 months of follow up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction\n2. Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm Human Acellular Vessel (HAV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.\n3. Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization\n4. Aged 18 to 85 years old, inclusive\n5. Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures\n6. Patient or relative is able, willing and competent to give informed consent\n7. Life expectancy of at least 1 year\n\nExclusion Criteria:\n\n1. Mangled Extremity Severity Score (MESS) of ≥ 7\n2. Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)\n3. Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) \\> 5 or Injury Severity Score (ISS) \\>60)\n4. HAV may not be used for coronary artery repair\n5. Known pregnant women\n6. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries\n7. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV\n8. Previous exposure to HAV\n9. Known participation in any investigational study within the last 30 days\n10. Employees of the sponsor or patients who are employees or relatives of the investigator'}, 'identificationModule': {'nctId': 'NCT03005418', 'briefTitle': 'Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Humacyte, Inc.'}, 'officialTitle': "A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma", 'orgStudyIdInfo': {'id': 'CLN-PRO-V005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Human Acellular Vessel (HAV)', 'description': 'Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.', 'interventionNames': ['Biological: Human Acellular Vessel (HAV)']}], 'interventions': [{'name': 'Human Acellular Vessel (HAV)', 'type': 'BIOLOGICAL', 'description': 'The investigational medicinal product (IMP) - the Human Acellular Vessel (HAV) is a sterile acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin which can be used for arterial bypass or reconstruction in patients with life or limb threatening vascular trauma. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The Humacyte HAV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.', 'armGroupLabels': ['Human Acellular Vessel (HAV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Jacob Medical Center at UC San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Hospital of University of Southern California (USC)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Cener', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UCI Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego (UCSD) Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Ernest E Moore Shock Trauma Center at Denver Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson South Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Ryder Trauma Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'R Adams Cowley Baltimore Shock Trauma', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University (SLU)', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78701', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas - Dell Medical School', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '8410101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center - Vascular Surgery Department', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus - Vascular Surgery Department', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '9103102', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '5265601', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center - Vascular Surgery Department', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Shamik Parikh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Humacyte, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humacyte, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Atlantic Research Group', 'class': 'OTHER'}, {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}