Critical Limb Ischemia Clinical Trial
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)
Verified date | October 2022 |
Source | Lisata Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 33 |
Est. completion date | May 19, 2022 |
Est. primary completion date | May 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility | Inclusion Criteria: - subject has CLI caused by ASO or BD Exclusion Criteria: - < 20 years old |
Country | Name | City | State |
---|---|---|---|
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 | Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou | Midorigaoka | Asahikawa-shi |
Japan | Oita Oka Hospital | Oita | |
Japan | Osaka Saiseikai Nakatsu Hospital | Osaka | |
Japan | Keio University Hospital | Tokyo | |
Japan | Nippon Medical School Hospital | Tokyo | |
Japan | Toho University Medical Center Ohashi Hospital | Tokyo | |
Japan | Tokyo Medical University Hospital | Tokyo | |
Japan | Tokyo Women's Medical University | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Lisata Therapeutics, Inc. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to continuous CLI-free status | CLI-free is determined by assessing the Rutherford score (=3) by the investigator and a central adjudication committee. | 1 year |
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