BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Is… (NCT02805023) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
United States, Israel40 participantsStarted 2016-06
Plain-language summary
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 have not responded to optimal pharmacological treatment or control of risk factors and/or had a revascularization failure, and do not have the option of further revascularization treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to complete the study and comply with instructions.
✓. Capable of understanding the purpose of the study and the contents of the informed consent form.
✓. Aged at least 18 years.
✓. Non-pregnant and non-lactating female patients.
✓. Have the clinical indications diagnostic of CLI based on Rutherford category 4-5
✓. Have at least one of the hemodynamic indicators of severe peripheral arterial occlusive disease (WIfI ischemia grade 2):
✓. 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.
Exclusion criteria
✕. Severe uncorrected aorto-iliac and/or common femoral artery disease, absent of femoral pulse or monophasic common femoral artery Doppler waveform.
✕. Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the feasibility of the study medication.
✕. Treatment with any investigational product within the last 6 months or enrollment in any active study involving the use of investigational devices or drugs.
✕. Presence of any other condition or circumstance that, in the judgment of the investigator, might negatively impact the outcomes of the treatment under investigation.
✕. Prognosis of a major amputation (below or above the knee), within 4 weeks after screening.
✕. Severe wound (WIfI wound grade 2 or 3).
✕. Significant ongoing infection (WIfI infection grade 2 or 3).
✕. Relative or absolute contraindications for intramuscular injections at the intended treatment site, in cases such as severe skin lesions, severe edema or morbid obesity, based on clinician opinion.