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Cell Therapy
Autologous Cell Therapy for Critical Limb Ischemia (EnEPC-CLI Trial)
Phase 1 & 2
Recruiting
Led By Michael Conte, MD
Research Sponsored by BioGenCell Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meeting one of the following conditions: Poor candidate for standard revascularization treatment for peripheral arterial disease due to unfavorable anatomy or high surgical/intervention risk based on the patient's underlying comorbidities. After undergoing clinically ineffective revascularization. Six weeks or more after undergoing a prior index limb revascularization the patient demonstrates: No improvement in clinical signs and symptoms of CLI as evidenced by lack of improvement in rest pain (when not under increased pain relief) and/or inadequate wound healing or progression of tissue loss despite adequate standard treatment. Ongoing ischemia as defined above in the criterion 6. The patient is no longer amenable to further interventional or surgical revascularization (see inclusion criterion 7).
Have the clinical indications diagnostic of CLI based on Rutherford category 4-5.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
EnEPC-CLI Trial 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.
Eligible Conditions
- Critical Limb Ischemia
- Peripheral Vascular Disease
- Peripheral Arterial Disease
EnEPC-CLI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
You have symptoms that indicate a severe blockage in your blood vessels, according to a specific scale called Rutherford category 4-5.
EnEPC-CLI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy (Improvement of indication signs)
Safety (Incidence of adverse events)
EnEPC-CLI 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
413 Previous Clinical Trials
125,969 Total Patients Enrolled
BioGenCell Ltd.Lead Sponsor
Laniado HospitalOTHER
15 Previous Clinical Trials
3,764 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to still sign up for this clinical trial?
"This study, which can be found on clinicaltrials.gov, is currently looking for participants. The listing was first posted on June 1st, 2016 and was last updated on November 7th, 2022."
Answered by AI
How many individuals are being analyzed in this clinical trial?
"The data on clinicaltrials.gov show that this trial is actively recruiting participants. The trial was first posted on 6/1/2016 and was last updated on 11/7/2022. The study is enrolling 50 participants at 1 location."
Answered by AI
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