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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Critical Limb Ischemia Buerger Disease Thromboangiitis Obliterans Atherosclerosis Obliterans | Biological: CLBS12 Drug: SOC | Phase 2 |
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 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 |

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 |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- subject has CLI caused by ASO or BD
Exclusion Criteria:
- < 20 years old

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
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 |
Study Director: | Kristen K Buck, MD | Lisata Therapeutics, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
CLI, ASO, TAO |
Atherosclerosis Thromboangiitis Obliterans Ischemia Pathologic Processes Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Vasculitis |