Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)
Condition: Critical Limb Ischemia; Buerger Disease; Thromboangiitis Obliterans; Atherosclerosis Obliterans
MeSH terms: Atherosclerosis; Chronic Limb-Threatening Ischemia; Thromboangiitis Obliterans; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      A prospective, open label, controlled, randomized, double arm, multi-center study to assess
      the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to
      arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and
      potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).
    

Detailed description: 
      Main ASO Study: This study will compare safety and efficacy of intramuscular transplantation
      of autologous CD34+ cells (CLBS12) plus standard of care (SOC) pharmacotherapy (cell
      treatment arm) versus SOC pharmacotherapy alone (e.g., antiplatelets, anticoagulants, and
      vasodilators including prostanoids) (control arm) in subjects with CLI categorized as
      Rutherford score 4 or 5 due to ASO aged 20 to 85 years and with no endovascular or surgical
      revascularization options. Subjects assigned to the cell treatment arm will continue SOC
      pharmacotherapy and will also receive subcutaneous injections of GRAN® 5 ug/kg/day for 5 days
      and undergo apheresis on the last day of GRAN® administration. Then each subject in the cell
      treatment arm will receive intramuscular injections of autologous CD34+ cells. Subjects
      assigned to the control arm will continue to receive SOC pharmacotherapy alone with the
      possibility of receiving cell treatment via the rescue option.

      BD Substudy: A single arm substudy is included to assess the safety and efficacy of
      intramuscular transplantation of CLBS12 in patients (N=~5) with CLI categorized as 4 or 5
      Rutherford score due to BD aged 20 to 85 years. Subjects who give informed consent will be
      screened for eligibility within 28 days before registration. Subjects will continue SOC
      pharmacotherapy and will also receive subcutaneous injections of GRAN® 5 µg/kg/day for 5 days
      (Pretreatment Days 1 5) to mobilize CD34+ cells into the peripheral blood and undergo
      apheresis on pretreatment Day 5 to collect CD34+ cells. The choice of pharmacotherapy will be
      made by the investigators.

      Each subject in a cell treatment arm will receive intramuscular injections of up to 1 × 10^6
      autologous CD34+ cells/kg/limb. All subjects will be evaluated for efficacy and safety
      assessments during approximately 12 months.

      Efficacy assessments include CLI free status, AFS, PFS, ABI, TBI, SPP, TcPO2, ICD, VAS, and
      AQA.
    

Intervention name(s): CLBS12; SOC
Intervention type(s): Biological; Drug
Intervention description(s): Intramuscular transfusion of CLBS12.; Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).
Other intervention name(s): CD34+ cells; Standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLI, ASO, TAO