Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:38 AM
Study NCT ID:
NCT07375160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D014648', 'term': 'Varicose Veins'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000620', 'term': 'Aminoimidazole Carboxamide'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Closure for Target Ulcer', 'timeFrame': 'Up to 8 months.', 'description': 'To evaluate the time to wound closure for patients treated with dHPT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Wound', 'Leg Wound', 'Amniotic', 'Allograft', 'Placenta'], 'conditions': ['Diabetic Foot Ulcer (DFU)', 'Venous Leg Ulcer (VLU)', 'Pressure Ulcer (PU)']}, 'descriptionModule': {'briefSummary': 'The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.', 'detailedDescription': "Around 10.5 million Medicare beneficiaries were affected by chronic wounds in 2019. A chronic wound is generally defined as any wound that fails to heal within a reasonable timeframe. Chronic wounds can be categorized into the following four groups: arterial, pressure, diabetic, and venous. Despite the well-established standard of care for chronic wounds, which includes sharp debridement, offloading, and maintaining proper moisture balance, a notable gap remains between historical outcomes and desired results in chronic wound care.\n\nOne approach to treating chronic wounds involves the use of dehydrated human placental tissues, which are defined as 'A broad category of biomaterials, synthetic materials, or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action. The application of dHTPs in chronic wound treatment provides several benefits, including creating a protective environment for healing, covering deep structures, aiding surgical closure, enhancing functional outcomes, and improving appearance. The cellular category of dHTPs includes allografts, which are human donor tissue samples intended for use in another human patient. Utilizing human amniotic membrane as an allograft displays considerable promise for chronic wound treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be drawn from wound clinic patient population that previously received treatment of their wound with a Cellution Biologics dHPT product', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* Wound treated with Cellution Biologics AmchoPlast, a dehydrated human placental tissue (dHPT).\n* Wound present for greater than or equal to 30 days prior to treatment with dHPT.\n* Wound is not infected.\n* Wound surface area is greater than 1cm2 at initial assessment.\n* Clinical documentation of wound treatment.\n\nExclusion Criteria:\n\n* AmchoPlast dHPT product was not applied to wound.\n* HbA1C \\>12%.\n* Presence of active osteomyelitis.\n* Concurrent treatment for malignant disease.\n* Use of other advanced biologics during treatment period.'}, 'identificationModule': {'nctId': 'NCT07375160', 'acronym': 'RETRO-PLAST', 'briefTitle': 'Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellution Biologics'}, 'officialTitle': 'A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing', 'orgStudyIdInfo': {'id': 'CELLBIO-2026-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dHPT, AIC', 'type': 'BIOLOGICAL', 'description': 'Sterile dehydrated Human Amnion - Intermediate Layer - Chorion Membrane Allograft'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bryanna Finstein', 'role': 'CONTACT', 'email': 'bryanna.f@cellutionbiologics.com', 'phone': '6035574660'}, {'name': 'Cellution Research', 'role': 'CONTACT', 'email': 'clinical@cellutionbiologics.com', 'phone': '6035574660'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellution Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}