Your session is about to expire
← Back to Search
Cell Therapy
Autologous Cell Therapy for Critical Limb Ischemia (EnEPC-CLI Trial)
Phase 1 & 2
Recruiting
Led By Moshe Halak, MD
Research Sponsored by BioGenCell Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Summary
This trial will test the feasibility of using a mix of cells enriched for endothelial progenitor cells and multipotent adult hematopoietic stem/progenitor cells to treat peripheral arterial disease and critical limb ischemia.
Who is the study for?
This trial is for adults with severe peripheral arterial disease and critical limb ischemia who haven't improved after standard treatments or can't have more surgery. They must not be pregnant, able to follow the study plan, and not have certain conditions like uncontrolled heart issues, recent major infections, liver failure, or a history of cancer within the last three years.
What is being tested?
The trial tests BGC101 (EnEPC), a cell therapy made from patients' own blood designed to treat critical limb ischemia when other treatments fail. It's compared against a control medium in patients who meet specific criteria for severe artery blockages.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with intramuscular injections such as pain at injection site, infection risk, and possible immune reactions due to the autologous nature of the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy (Improvement of indication signs)
Safety (Incidence of adverse events)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BGC101Experimental Treatment1 Intervention
Intramuscular injection of BGC101 (autologous EnEPC preparation)
Group II: PlaceboPlacebo Group1 Intervention
Intramuscular injection of control medium only
Find a Location
Who is running the clinical trial?
Rabin Medical CenterOTHER
417 Previous Clinical Trials
146,790 Total Patients Enrolled
BioGenCell Ltd.Lead Sponsor
Laniado HospitalOTHER
16 Previous Clinical Trials
3,788 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe and untreated blockages in the major arteries in your legs.You are at risk of having a major amputation of your leg within 4 weeks after screening.You have conditions, like severe skin problems, extreme swelling, or severe obesity, that make it risky to get injections in the planned treatment area, according to your doctor's opinion.You have severe liver disease with a MELD score of 15 or higher.You have severe blockages in your leg arteries, as shown by specific low pressure measurements.You have any other health issues that could make the treatment less effective.You have long-term infections like HIV, hepatitis B, or hepatitis C.You have had cancer, except for a type called basal cell carcinoma, within the last 3 years.You currently have a severe infectious disease with bloodstream infection.Your blood clotting tests are abnormal when you are not taking warfarin (PT INR >2).You have a severe wound graded as WIfI grade 2 or 3.You have a serious ongoing infection.You have received a blood transfusion in the last 4 weeks.Your kidneys are not working well, with an eGFR less than 30 mL/min/1.73 m², or you have severe chronic kidney damage.Your liver function tests show levels more than three times the normal limit.You have Raynaud's syndrome.You are currently receiving strong medications that weaken your immune system.You have symptoms that indicate a severe blockage in your blood vessels, according to a specific scale called Rutherford category 4-5.You have ongoing inflammation of blood vessels.Your hemoglobin level is lower than 9 grams per deciliter.Your HbA1C level is higher than 8.5%.You are not a good candidate for standard treatment for peripheral arterial disease because of difficult anatomy or high risk due to other health issues. If you had a previous limb treatment that did not help and you still have pain or tissue loss, and you are not eligible for more treatment, then you can join the study.You have a weakened immune system.You have severe heart failure, classified as New York Heart Association (NYHA) class 3 or 4.You have had a heart attack or severe heart problems within the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: BGC101
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger