Your session is about to expire
← Back to Search
HAV for Peripheral Arterial Disease
Study Summary
This trial will study whether Humacyte's Human Acellular Vessel can improve blood flow in patients with peripheral arterial disease, as well as how safe the treatment is.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 15 Patients • NCT02887859Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You have a serious infection in your body.You have a documented condition that makes your blood clot more easily, or you have a history of blood clots.You had a stroke within the six months before the study starts.You have a narrowing of more than 50% in the main artery leading to the same side as the leg being studied.You have had surgery to create a new path for blood flow in your leg using a vein or synthetic tube.You have an ongoing autoimmune disease that is causing symptoms or needs regular medication.You have severe peripheral arterial disease that limits your ability to walk or do daily activities, or you need surgery for it.Before surgery, tests show a blockage in the superficial femoral artery, and the length of the Humacyte Human Acellular Vessel needed is 38cm or less.You have AIDS or HIV.You are currently taking certain types of blood thinning medications.The surgery involves connecting a blood vessel to an artery below the knee.Your diabetes is not well controlled, with a high HbA1c level above 10%.You are currently receiving chemotherapy for cancer.You have not responded well to previous treatments, including exercise, quitting smoking, managing diabetes, controlling high blood pressure, managing high cholesterol, and taking medication to prevent blood clots.Your ankle-brachial index in the study leg is less than or equal to 0.6.Your liver is working well, with bilirubin and INR levels within a certain range.Before surgery, the pictures of your leg show that at least one blood vessel below your knee is open and working well all the way to your ankle.You have had unexplained bleeding issues in the past 5 years.You have a severe allergy to aspirin.You have been previously exposed to hepatitis A virus.You have a severe condition in your leg that may require amputation.You have had a serious injury to the leg that will receive the treatment.You must be between 18 and 85 years old.The surgeon doesn't think using your own vein for grafting is a good idea.Your blood has enough hemoglobin and platelets.You have a serious infection in the leg where the treatment is supposed to be given.You have a history of serious heart problems.You have a kidney problem where using contrast agents could be risky (eGFR<45mL/min).The surgery will connect the hepatic artery to the common femoral artery below a specific area in the leg.The surgery will connect to an artery above the knee.You have a blockage in the main artery in your thigh and it cannot be treated with a certain type of procedure.Your blood and other body chemistry levels are within normal range for receiving anesthesia.You are expected to live for at least 1 year.
- Group 1: HAV Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Have there been any previous investigations involving Human Acellular Vessel (HAV)?
"The first clinical trials of Human Acellular Vessel (HAV) were conducted at St. George's Hospital in 2016, with a total of 7 completed studies thus far. Presently, 6 active trials are underway primarily based out of Flint, Michigan."
Does the age criteria for this research protocol extend below 35 years of age?
"Patients hoping to be a part of this medical experiment must fall in the 18-85 age bracket. Additionally, there are 11 trials available for minors and 216 studies catered towards elderly individuals."
Is this research pioneering in its field?
"To date, 6 studies on Human Acellular Vessel (HAV) are active in 8 different countries and 69 cities. Humacyte Inc.'s first clinical trial for HAV began in 2016 and involved 355 patients; it concluded its Phase 3 stage of drug approval. Since then, 7 trials have been completed."
What is the current estimated enrollment of participants for this investigation?
"Unfortunately, this clinical trial is not accepting patients at the present moment. Initially posted on December 20th 2016 and last updated on December 6th 2021, it has become dormant. However, if you are seeking alternative medical trials enrolling subjects with peripheral arterial disease ,there exist 217 such studies currently recruiting while a further 6 trials are looking for Human Acellular Vessel (HAV) participants."
How many centers are overseeing this trial?
"Currently, there are 5 clinical trial sites offering this particular study, such as Michigan Vascular Center located in Flint, Brigham and Women's Hospital residing in Boston, and UCSF situated within San Francisco. In addition to these 3 locations, 2 more are available for patient recruitment."
Do I meet the criteria for participation in this experiment?
"Applicants must meet the inclusion criteria of being afflicted with peripheral arterial disease and within 18 to 85 years old in order to be considered for this clinical trial. A maximum of 15 participants will be accepted into the program."
Are there any vacancies left to participate in this examination?
"This investigation is no longer recruiting; the initial posting was on 20th December 2016, and it was modified for the last time on 6th December 2021. If you are seeking other trials, 217 investigations targeting peripheral arterial disease and 6 involving Human Acellular Vessels (HAV) are actively accepting new participants."
Has the FDA accorded clearance to Human Acellular Vessel (HAV)?
"The safety of Human Acellular Vessel (HAV) has been estimated as a 2 due to the fact that it is still in Phase 2. There are preliminary data supporting its security profile, but none yet indicating efficacy."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger