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

NCT ID: NCT02501018

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2022-05-19

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CLI Due to ASO with CLBS12 + SOC

This group of subjects with CLI due to ASO will be administered with CLBS12 + SOC for collecting efficacy and safety data.

Group Type: EXPERIMENTAL

CLBS12

Intervention Type: BIOLOGICAL

Intramuscular transfusion of CLBS12.

SOC

Intervention Type: DRUG

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

CLI Due to ASO with SOC

This group of subjects with CLI due to ASO will be administered with SOC only.

Group Type: ACTIVE_COMPARATOR

SOC

Intervention Type: DRUG

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

CLI Due to BD with CLBS12

CLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data.

Group Type: EXPERIMENTAL

CLBS12

Intervention Type: BIOLOGICAL

Intramuscular transfusion of CLBS12.

SOC

Intervention Type: DRUG

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

Interventions

CLBS12

Intramuscular transfusion of CLBS12.

Intervention Type: BIOLOGICAL

SOC

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

Intervention Type: DRUG

Other Intervention Names

CD34+ cells; Standard of care

Eligibility Criteria

Inclusion Criteria

• subject has CLI caused by ASO or BD

Exclusion Criteria

• < 20 years old

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lisata Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristen K Buck, MD

Role: STUDY_DIRECTOR

Lisata Therapeutics, Inc.

Locations

Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou

Midorigaoka, Asahikawa-shi, 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

Osaka Saiseikai Nakatsu Hospital

Osaka, , Japan

Oita Oka Hospital

Ōita, , Japan

Nippon Medical School Hospital

Tokyo, , Japan

Keio University Hospital

Tokyo, , Japan

Toho University Medical Center Ohashi Hospital

Tokyo, , Japan

Tokyo Medical University Hospital

Tokyo, , Japan

Tokyo Women's Medical University

Tokyo, , Japan

Countries

Japan

Other Identifiers

CLBS12-P01

Identifier Type: -

Identifier Source: org_study_id