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Ixmyelocel-T · 6 trials · 5 indications
The primary objective will be to assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on AFS at 12 months post-injection in CLI patients with no options for revascularization. Amputation free survival is defined as time to the first occurrence of either major amputation (above the talus) in the index leg or all-cause mortality (death).
The primary endpoint will assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average number of events per patient over 12 months post-treatment in each treatment arm (total number events in each arm/total number of patients in each arm). The events include: all-cause deaths, cardiovascular hospitalizations, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure. The clinical events used in this endpoint will be adjudicated by an independent clinical endpoint committee who are blinded to treatment.
| Arm | Type | Description |
|---|---|---|
| ixmyelocel-T | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Standard of Care Only | ACTIVE_COMPARATOR | Core decompression, demineralized bone matrix bound in autologous plasma, without any TRCs. |
| Vehicle Control | PLACEBO_COMPARATOR | will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control. |
| Standard of Care | OTHER | Standard of care therapy only. |
| Name | Type | Description |
|---|---|---|
| Ixmyelocel-T | BIOLOGICAL | On Day 14, 20 intramuscular injections of ixmyelocel-T on pre-identified index leg. |
| Placebo | OTHER | On Day 14, 20 intramuscular injections of vehicle control on pre-identified index leg. |
| Standard of Care Only | OTHER | Core decompression of the femoral head to remove necrotic tissue |
| Vehicle Control | OTHER | will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle. |
| Standard of Care | OTHER | Because the eligible patients had no other cardiac surgery or percutaneous cardiac interventions that were likely to produce clinical improvement, SOC was limited to pharmacologic therapy, heart transplant, or ventricular assist device therapy. |
Inclusion Criteria: * Males and nonpregnant, nonlactating females * Ages 35 to 90 years of age * Diagnosis of CLI with tissue loss (corresponding to Rutherford Category 5; see Appendix B) having an ulcer size of at least 0.5 cm2, a smaller sized ulcer penetrating into the subcutaneous tissue, and/o...