Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLBS14 · 1 trial · 1 indication
The number of angina episodes were collected via an electronic subject diary for four weeks at Baseline and at 6 and 12 months. The four-week angina episodes (per week mean) were used as the frequency for each visit. A lower number represents fewer angina episodes. A lower number is better.
| Arm | Type | Description |
|---|---|---|
| CLBS14: Low-Dose Group | EXPERIMENTAL | 10 intramyocardial injections of 0.2 mL each of auto-CD34+ cells at a dose of 1 x 10\^5 (=100000) cells/kg bodyweight |
| CLBS14: High-Dose Group | EXPERIMENTAL | 10 intramyocardial injections of 0.2 mL each of auto-CD34+ cells at a dose of 5 x 10\^5 (=500000) cells/kg bodyweight |
| Placebo injection | PLACEBO_COMPARATOR | 10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma |
| Name | Type | Description |
|---|---|---|
| CLBS14 (low-dose) | BIOLOGICAL | Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 1 x 10\^5 (=100000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia. |
| CLBS14 (high-dose) | BIOLOGICAL | Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 5 x 10\^5 (=500000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia. |
| placebo injection | BIOLOGICAL | Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Placebo will be delivered in 10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma into the target areas of myocardial ischemia. |
Inclusion Criteria: * Canadian Cardiovascular Society (CCS) functional class III or IV chronic refractory angina * subjects without control of their angina symptoms, in spite of maximal tolerated doses of anti-anginal drugs, must be on optimal therapy for their angina and on a stable anti-anginal m...
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.