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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02501018 |
|
Recruitment Status :
Recruiting
First Posted : July 17, 2015
Last Update Posted : October 16, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Limb Ischemia (CLI) | 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 80 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 80 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) |
| Estimated Enrollment : | 35 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 |
| Estimated Primary Completion Date : | January 2020 |
| Estimated Study Completion Date : | July 2020 |
| 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 grop 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 80 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
| Contact: Scott Volk | 9493468784 | svolk@caladrius.com |
| Japan | |
| Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou | Recruiting |
| Midorigaoka, Asahikawa-shi, Japan, 078-8510 | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Fukuoka Sanno Hospital | Recruiting |
| Fukuoka, Japan | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Shonan Kamakura General Hospital | Recruiting |
| Kamakura, Japan | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Kobe City Medical Center General Hospital | Recruiting |
| Kobe, Japan | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Shinsuma General Hospital | Not yet recruiting |
| Kobe, Japan | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Osaka Saiseikai Nakatsu Hospital | Recruiting |
| Osaka, Japan | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Nippon Medical School Hospital | Recruiting |
| Tokyo, Japan, 113-8603 | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Toho University Medical Center Ohashi Hospital | Recruiting |
| Tokyo, Japan | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Tokyo Medical University Hospital | Recruiting |
| Tokyo, Japan | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
| Tokyo Women's Medical University | Recruiting |
| Tokyo, Japan | |
| Contact: Yoshiyuki Takahashi +81 78 304 7316 takahashi@fbri.org | |
Additional Information:
| Responsible Party: | Caladrius Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT02501018 History of Changes |
| Other Study ID Numbers: |
CLBS12-01 |
| First Posted: | July 17, 2015 Key Record Dates |
| Last Update Posted: | October 16, 2018 |
| Last Verified: | October 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Caladrius Biosciences, Inc.:
|
CLI |
Additional relevant MeSH terms:
|
Ischemia Arteriosclerosis Obliterans Pathologic Processes Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |