Join a Journey that Brings New Hope
to No-Option Patients
BioGenCell’s Phase 2 Clinical Trial for BGC 101
Double blind randomized placebo controlled study to assess the feasibility of BGC101(EnEPC) in treating Critical Limb Ischemia.
If you are a Physician, you can contact us for more information or refer patients
If you are a patient, a patient’s family member, or an interested party
Quick Overview
We’re Actively Recruiting
Age & Gender
- Age > 18
- All Genders
Conditions
- No-Option Critical Limb Ischemia (CLI)
- Rutherford 4-5
- Severe Peripheral Occlusive Arterial Disease
- Not Amenable to Further Revascularization
Testing
- Safety
- Amputation Free Survival
Principal Investigators (PIs)
-
Prof. Michael Conte
University of California San Francisco (UCSF),USA; Committee for the Diagnosis and Treatment of Chronic Limb-Threatening Ischemia -
Dr. Edouard Aboian
Yale University, USA -
Dr. Caitlin W. Hicks
Johns Hopkins Hospital, USA -
Dr. Shlomo Baytner
Sanz Medical Center - Laniado Hospital, Israel -
Dr. Tony Karram
Rambam Medical Center, Israel -
Dr. George Grinberg
Soroka Hospital, Israel
Inclusion and
Exclusion Criteria
Inclusions
- Age > 18
- Both genders
- Rutherford 4-5
- Rest pain
- Non-healing ischemic ulcers
- Minor tissue loss
- Severe peripheral arterial occlusive disease
- Toe pressure < 40 mmHg
- Ankle pressure < 70 mmHg
- TcPO2 < 40mmHg
- Unsuitable for standard revascularization
- >6 Weeks after revascularization with no improvement in clinical signs and symptoms of CLI
- The patient is no longer amenable to further revascularization
Exclusions (partial list)
- Other therapy that may interfere with the study therapy
- Participating in other studies within the last 6 months
- Prognosis of a major amputation within 4 weeks
- Hb <9 gr/dL
- Lack of femoral artery blood flow
- Inability to perform intramuscular injections
- Blood transfusions within last 4 weeks
- Severe heart / valve / renal / liver disease
- MI / brain infarction within last 3 months
- Malignancy within 3 years except for BCC
- Cytotoxic drugs treatment
- Abnormal coagulation
- Immunodeficiency syndrome
- Pregnancy
- Chronic infectious diseases (HIV-1,HIV-2, HBV, HCV)
- Inability to communicate and follow-up
HealthCare Providers
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For Healthcare Providers
Patients over 18 years old, of all genders, suffering from No-Option Chronic Limb Threatening Ischemia, Rutherford 4-5, with Severe Arterial Occlusive Peripheral Disease and not amenable for further revascularization.
Patients and Their Families
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Patients and Their Families
Patients over 18 years old, of all genders, suffering from No-Option Chronic Limb Threatening Ischemia, Rutherford 4-5, with Severe Arterial Occlusive Peripheral Disease and not amenable for further revascularization.
The Science: Hind-Limb Ischemia as a Model
for Vascular Diseases and CLI
Incorporation in the tissue, increased capillary density & perfusion are concentrated in and restricted to the injured area to provide maximal benefit without untoward effects.
Study Design
- Nude mice
- Intramuscular injections
- Dose range (MRSD x1-x5)
- Healy & Diabetic donors
Safety
- No clinical signs
- Clean Pathology
- Clean Toxicity
- Bio-distribution – No traces of humancells