Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Summary

Conditions
  • Critical Limb Ischemia
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

BGC101 is designed to treat peripheral vascular disease in patients suffering from Critical Leg Ischemia (CLI) also referred to as chronic limb threatening ischemia (CLTI). This part of the study is designed as a placebo double-blind randomized controlled trial (CRT) assessing the safety and efficac...

BGC101 is designed to treat peripheral vascular disease in patients suffering from Critical Leg Ischemia (CLI) also referred to as chronic limb threatening ischemia (CLTI). This part of the study is designed as a placebo double-blind randomized controlled trial (CRT) assessing the safety and efficacy of BGC101 in 45 eligible subjects in 2 Arms: Arm A: BGC101 treatment and Arm B: Placebo treatment. The Arm A:Arm B ratio is 2:1 A single dose treatment of the personalized cells by intramuscular injections into the affected leg takes less than 10 minutes. Cells from a standard blood draw (with no pre-treatment, bone marrow aspiration, mobilization or apheresis) are transformed, within a day, into the investigational medicinal product BGC101. BGC101, intended for autologous use, is a 'ready-to-use' cell suspension in prefilled syringes.

Tracking Information

NCT #
NCT02805023
Collaborators
  • Laniado Hospital
  • Rabin Medical Center
Investigators
Principal Investigator: Shlomo J Baytner, MD Director of Vascular Surgery, Laniado Hospital, IL Principal Investigator: Michael Conte, MD University of San Francisco - Division Vascular and Endovascular surgery
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