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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501018
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Lisata Therapeutics, Inc.

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.

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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501018


Locations
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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
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Study Director: Kristen K Buck, MD Lisata Therapeutics, Inc.
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Responsible Party: Lisata Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02501018    
Other Study ID Numbers: CLBS12-P01
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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