Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)

Critical Limb Ischemia Clinical Trial

Official title:

A Prospective, Open Label, Controlled, Randomized, Multicenter 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 Substudy to Assess the Safety and Potential Efficacy of CLBS12 in Patients With CLI Due to Buerger's Disease (BD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501018
• Other study ID #: CLBS12-P01
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2017
• Est. completion date: May 19, 2022

Study information

• Verified date: October 2022
• Source: Lisata Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• subject has CLI caused by ASO or BD

Exclusion Criteria:

• < 20 years old

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis Obliterans
• Buerger Disease
• Critical Limb Ischemia
• Ischemia
• Thromboangiitis Obliterans

Intervention

Biological:
• CLBS12
Intramuscular transfusion of CLBS12.

Drug:
• SOC
Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).

Locations

Country	Name	City	State
Japan	Fukuoka Sanno Hospital	Fukuoka
Japan	Shonan Kamakura General Hospital	Kamakura
Japan	Kobe City Medical Center General Hospital	Kobe
Japan	Shinsuma General Hospital	Kobe
Japan	Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou	Midorigaoka	Asahikawa-shi
Japan	Oita Oka Hospital	Oita
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka
Japan	Keio University Hospital	Tokyo
Japan	Nippon Medical School Hospital	Tokyo
Japan	Toho University Medical Center Ohashi Hospital	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Tokyo Women's Medical University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Lisata Therapeutics, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to continuous CLI-free status	CLI-free is determined by assessing the Rutherford score (	1 year