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

• ClinicalTrials.gov Identifier: NCT02501018
• Recruitment Status: Completed
• First Posted: July 17, 2015
• Last Update Posted: October 28, 2022
• Sponsor: Lisata Therapeutics, Inc.
• Information provided by (Responsible Party): Lisata Therapeutics, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Critical Limb Ischemia; Buerger Disease; Thromboangiitis Obliterans; Atherosclerosis Obliterans	Biological: CLBS12; Drug: SOC	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: November 1, 2017
• Actual Primary Completion Date: May 19, 2022
• Actual Study Completion Date: May 19, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Biological: CLBS12; Intramuscular transfusion of CLBS12.; Other Name: CD34+ cells; Drug: SOC; Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).; Other Name: Standard of care
Active Comparator: CLI Due to ASO with SOC; This group of subjects with CLI due to ASO will be administered with SOC only.	Drug: SOC; Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).; Other Name: Standard of care
Experimental: CLI Due to BD with CLBS12; CLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data.	Biological: CLBS12; Intramuscular transfusion of CLBS12.; Other Name: CD34+ cells; Drug: SOC; Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).; Other Name: Standard of care

Outcome Measures

Primary Outcome Measures :

1. Time to continuous CLI-free status [ Time Frame: 1 year ]
   CLI-free is determined by assessing the Rutherford score (</=3) by the investigator and a central adjudication committee.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• subject has CLI caused by ASO or BD

Exclusion Criteria:

• < 20 years old

Contacts and Locations

Locations

Japan

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

Midorigaoka, Asahikawa-shi, Japan, 078-8510

Fukuoka Sanno Hospital

Fukuoka, Japan

Shonan Kamakura General Hospital

Kamakura, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

Shinsuma General Hospital

Kobe, Japan

Oita Oka Hospital

Oita, Japan

Osaka Saiseikai Nakatsu Hospital

Osaka, Japan

Nippon Medical School Hospital

Tokyo, Japan, 113-8603

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

Sponsors and Collaborators

Lisata Therapeutics, Inc.

Investigators

• Study Director: Kristen K Buck, MD; Lisata Therapeutics, Inc.

More Information

• Responsible Party: Lisata Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02501018
• Other Study ID Numbers: CLBS12-P01
• First Posted: July 17, 2015
• Last Update Posted: October 28, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lisata Therapeutics, Inc.:

CLI, ASO, TAO

Additional relevant MeSH terms:

Atherosclerosis; Thromboangiitis Obliterans; Ischemia; Pathologic Processes; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis