- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03631056
Individual Patient Expanded Access for Human Acellular Vessel (HAV)
Study Overview
Status
Intervention / Treatment
Detailed Description
Procedure for Requesting Expanded Access:
The treating physician requesting expanded access must contact Humacyte directly with the basis for the request. Please include your contact information so that Humacyte may follow up with you directly.
General Criteria:
We will evaluate and respond to each expanded-access request that we receive on a case-by-case basis. Humacyte will consider the nature of the request, the patient's health, the available medical and scientific information about the investigational product, the balance of risk and potential benefit to the patient, the availability of investigational product, and the potential regulatory impact.
Anticipated Timing:
If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.
Study Type
Expanded Access Type
- Individual Patients
Contacts and Locations
Study Contact
- Name: Mauricio Berdugo, MD, MPH
- Phone Number: 233 919-313-9633
- Email: mberdugo@humacyte.com
Study Contact Backup
- Name: Mark Tulchinskiy, MD, MBA
- Phone Number: 919-313-9633
- Email: mtulchinskiy@humacyte.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-
Exclusion Criteria:
-
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Kidney Diseases
- Urologic Diseases
- Wounds and Injuries
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Vascular Diseases
- Kidney Failure, Chronic
- Vascular System Injuries
Other Study ID Numbers
- CLN-EA-IP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vascular Diseases
-
Terumo Europe N.V.CompletedPeripheral Vascular Disease | Hemostasis | Vascular Closure | Endovascular ProcedureBelgium, France, Germany
-
University Hospital, MontpellierTerminated
-
Alvotech Swiss AGActive, not recruitingChorioretinal Vascular DiseaseGeorgia
-
University of California, IrvineUniversity of Oklahoma; US Department of Veterans Affairs; C. R. Bard; Long Beach...CompletedPeripheral Vascular Disease | Cardiac Catheterization | Vascular Access ComplicationsUnited States
-
AmgenCompletedChorioretinal Vascular DiseaseUnited States
-
Duke UniversityTerminatedRetinal Vascular DiseaseUnited States
-
Baylor UniversityNational Institute on Aging (NIA)RecruitingArterial Occlusive Diseases | Peripheral Arterial Disease | Atherosclerosis | Vascular Diseases, PeripheralUnited States
-
C. R. BardCromsourceCompletedVascular Diseases, PeripheralGermany, Poland
-
Regeneron PharmaceuticalsCompletedChorioretinal Vascular DiseaseUnited States
-
Terumo Europe N.V.Terumo Medical CorporationRecruitingPeripheral Vascular Disease | Hemostasis | Vascular Closure | Femoral Artery | Endovascular ProcedureFrance, Germany, Netherlands
Clinical Trials on Human Acellular Vessel (HAV)
-
Humacyte, Inc.Atlantic Research GroupCompletedPeripheral Artery DiseaseUnited States
-
Humacyte, Inc.FGK Clinical Research GmbHActive, not recruitingPeripheral Arterial Disease | Peripheral Vascular DiseasePoland
-
Humacyte, Inc.California Institute for Regenerative Medicine (CIRM); CTI Clinical Trial and...Active, not recruitingRenal Failure | Hemodialysis | End Stage Renal Disease | Vascular AccessUnited States
-
Humacyte, Inc.U.S. Army Medical Research and Development Command; Atlantic Research GroupActive, not recruitingTrauma | Vascular System InjuryUnited States, Israel
-
Humacyte, Inc.California Institute for Regenerative Medicine (CIRM); CTI Clinical Trial and...CompletedRenal Failure | Hemodialysis | End Stage Renal Disease | Vascular AccessUnited States, Israel, United Kingdom, Portugal, Poland, Germany
-
Henry Ford Health SystemCompleted
-
Musculoskeletal Transplant FoundationWashington University School of Medicine; Pines Surgical; Meridian Healthcare...CompletedHernia of Abdominal WallUnited States
-
Humacyte, Inc.FGK Clinical Research GmbHActive, not recruitingKidney Failure, Chronic | End-stage Renal DiseasePoland
-
SGM Physician Research ConsortiumMusculoskeletal Transplant FoundationCompletedLower Eyelid RetractionUnited States
-
Zimmer BiometZimmer DentalCompletedGingival RecessionUnited States