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Auto-CD34+ cells · 1 trial · 3 indications
Baseline (BL) is the average of the two total exercise times measured during the screening period.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis |
| Active Control Arm | PLACEBO_COMPARATOR | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis |
| Unblinded Standard of Care (SOC) Arm | OTHER | No study-related procedures will be performed. |
| Name | Type | Description |
|---|---|---|
| Auto-CD34+ cells | BIOLOGICAL | 10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells |
| Placebo: Diluent used to suspend Auto-CD34+ cells | BIOLOGICAL | 10 intramyocardial injections of 0.2 mL per injection site of placebo |
| Standard of care | OTHER | Standard of care for refractory angina |
Main Inclusion Criteria: * Male or female participants who are 21 to 80 years of age at the time of signing the informed consent. * Participants with Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina. * Participants without control of their angina symptoms in spite of ...
Auto-CD34+ cells is an investigational therapy being studied for the treatment of Chronic Myocardial Ischemia, specifically in patients with refractory angina and advanced coronary heart disease. It is delivered via targeted intramyocardial injection to improve exercise capacity in these patients.
Auto-CD34+ cells is a cell therapy that uses the patient's own CD34+ stem cells. These cells are collected and then delivered directly into the heart muscle to promote the growth of new blood vessels, potentially improving blood flow to areas of the heart affected by chronic ischemia.
Auto-CD34+ cells is being developed by Lisata Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LSTA.
Auto-CD34+ cells is in Phase 3 clinical development. It is an investigational therapy and has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its efficacy and safety.
Auto-CD34+ cells has been studied in one completed Phase 3 clinical trial, identified as NCT01508910. This randomized, double-blind, placebo-controlled trial enrolled 291 participants with chronic myocardial ischemia and refractory angina to assess the therapy's effect on exercise capacity.
Auto-CD34+ cells refers to a specific autologous CD34+ stem cell therapy, meaning it uses the patient's own cells. It is a form of CD34+ stem cell therapy, but the term 'Auto-CD34+ cells' specifically denotes the autologous approach being developed by Lisata Therapeutics.