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Also known as CLBS14 (low-dose), CLBS16, CLBS12, CLBS03 Low Dose
CLBS14 · 4 trials · 7 indications
Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
CLI-free is determined by assessing the Rutherford score (\</=3) by the investigator and a central adjudication committee.
The area-under-curve of sequential C-peptide concentrations (AUC-Cpep) during the mixed-meal tolerance test (MMTT) is the gold-standard method to assess residual beta-cell (ie, insulin) secretion in type 1 diabetes.
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 |
|---|---|---|
| Autologous CD34 cells | EXPERIMENTAL | Open label active treatment arm. Subjects receive autologous CD34 cells. |
| 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. |
| CLBS03 Low Dose | EXPERIMENTAL | A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution. |
| CLBS03 High Dose | EXPERIMENTAL | A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution. |
| Placebo | PLACEBO_COMPARATOR | A single infusion of placebo, consisting of the infusion solution only |
| 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 |
|---|---|---|
| CLBS16 | BIOLOGICAL | GCSF-mobilized autologous CD34 cells |
| 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). |
| CLBS03 Low Dose | BIOLOGICAL | - |
| CLBS03 High Dose | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
| 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: * Men or women age ≥18 * History of and currently experiencing angina at least 3 times per week * No obstructive coronary artery disease * On stable medical therapy for 30 days prior to enrollment * Must agree to use a reliable and acceptable method of contraception for the dura...
CLBS14 is an investigational therapy being studied for cardiovascular and metabolic conditions, including coronary microvascular dysfunction, critical limb ischemia, diabetes mellitus, and myocardial ischemia. It is being developed by Lisata Therapeutics, Inc. (ticker: LSTA) and is currently in Phase 2 clinical development.
CLBS14 is being developed by Lisata Therapeutics, Inc., which trades under the ticker LSTA. The company is advancing the asset through Phase 2 clinical trials across cardiovascular and metabolic indications.
CLBS14 is in Phase 2 clinical development. It has completed one Phase 2 trial and is not currently listed as having active trials. The drug remains investigational and has not been approved by the FDA.
CLBS14 has been evaluated in completed Phase 2 trials, including NCT03508609 in coronary microvascular dysfunction, NCT02691247 in type 1 diabetes, NCT02501018 in critical limb ischemia, and NCT00300053 in myocardial ischemia. These studies enrolled a combined total of 321 participants.
Yes, CLBS14 is also known as CLBS14 (low-dose), CLBS16, CLBS12, and CLBS03 Low Dose. These alternative names refer to the same investigational asset being developed by Lisata Therapeutics, Inc. for cardiovascular and metabolic indications.