Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLBS12 · 1 trial · 4 indications
CLI-free is determined by assessing the Rutherford score (\</=3) by the investigator and a central adjudication committee.
| Arm | Type | Description |
|---|---|---|
| CLI Due to ASO with CLBS12 + SOC | EXPERIMENTAL | This group of subjects with CLI due to ASO will be administered with CLBS12 + SOC for collecting efficacy and safety data. |
| CLI Due to ASO with SOC | ACTIVE_COMPARATOR | This group of subjects with CLI due to ASO will be administered with SOC only. |
| CLI Due to BD with CLBS12 | EXPERIMENTAL | CLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data. |
| Name | Type | Description |
|---|---|---|
| CLBS12 | BIOLOGICAL | Intramuscular transfusion of CLBS12. |
| SOC | DRUG | Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids). |
Inclusion Criteria: * subject has CLI caused by ASO or BD Exclusion Criteria: * \< 20 years old
CLBS03 Low Dose is an investigational cell therapy being studied for use in diabetes mellitus, specifically in adolescents with recent onset type 1 diabetes. It is in Phase 2 clinical development and is not yet approved by the FDA.
CLBS03 Low Dose is being developed by Lisata Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol LSTA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.
CLBS03 Low Dose is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness.
CLBS03 Low Dose was evaluated in a completed Phase 2 clinical trial with NCT number NCT02691247, titled 'Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes.' This trial enrolled 113 participants in the United States.
CLBS03 Low Dose is a specific dosage form of the investigational therapy CLBS03. The clinical trial NCT02691247 studied CLBS03 in adolescents with recent onset type 1 diabetes, and the low dose refers to one of the dosage levels being evaluated in that study.