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  • Actively Enrolling

Help Your Patients Discover a Potential Treatment Option for Chronic Limb-Threatening Ischemia (CLTI)

Interested in referring patients?

Click here
info@biogencell.net

Phase 2 Clinical Trial:

Double blind randomized placebo controlled study to assess the feasibility of BGC101 (EnEPC) in treating PAD & CLI.

Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the treatment of patients suffering from peripheral arterial disease (PAD) with critical limb ischemia (CLI) who do not have the option of further revascularization treatment.

ClinicalTrials.Gov Identifier: NCT02805023

Age & Gender

  • Age > 18
  • All Genders

Conditions

  • No-Option Chronic Limb-Threatening Ischemia (CLTI)
  • Rutherford 4-5
  • Severe Peripheral Occlusive Arterial Disease
  • Not Amenable to Further Revascularization

Testing

  • Safety
  • Amputation Free Survival
Click here

To see the Inclusion
and Exclusion Criteria

About
BioGenCell:

BioGenCell is dedicated to changing the lives of patients suffering from degenerative microvascular diseases.

We do so using revolutionary cell-therapy treatments aimed at significantly reducing pain and enhancing functionality.

Our Ground-Breaking TRACT Solution:
Tissue Regenerative Activated Cell Therapy

Transforming Patients' Blood into a Life-Saving Medicine In 1 Day:

About BioGenCell

The Advantages of the BioGenCell Treatment:

rapid
patient-friendly
accessible
clinician-friendly
lasting-effect
personalized

Who May Qualify

Referring patients to a clinical study is an important decision.

Thank you for considering this study.

BioGenCell is dedicated to reducing the suffering of No-Option Critical Limb Ischemia (CLI) patients:

  • No response to available treatments
  • No option of revascularization treatment
  • High risk of leg amputation

See the List Below to Learn More About Our Participation Criteria

Contact us

Long Lasting Effect

long-lasting-effect

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
  • cPO2 < 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, eligible less than 4 weeks after revascularization failure

Exclusions (partial list)

Severe and corrected aorto-iliac disease, absence of femoral pulse

Concurrent therapy that might interfere with the evaluation of the effect

Prognosis of a major amputation within 4 weeks

Hemoglobin (Hb) less than 9 gr/dL

Severe wound (Wlfl wound grade 2 or 3)

Severe infection (Wlfl infection grade 2 or 3)

Blood transfusions within last 4 weeks

Diabetes HbA1C over 8.5%

Infectious disease (HIV-1, HIV-2, HBV, HCV) acute infectious disease with septicemia

Abnormal coagulation tests

Severe Heart / Valve / Renal (eGFR less than 30) / Liver diseases / Stroke

Malligancy within the last 3 years (except basal cell carcinoma)

Active vasculities

Immunodeficiency syndrome

Treatment with cytotoxic and/or immunosuppressive treatment

Inability to communicate and be available for follow-up

Does Your Patient
Qualify for our Trial?

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