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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...
Ixmyelocel-T is an investigational cell therapy being developed for cardiovascular conditions, including peripheral arterial disease, dilated cardiomyopathy, ischemic dilated cardiomyopathy (IDCM), osteonecrosis, and critical limb ischemia. It is administered via catheter-based injections directly into the heart or affected tissue. The drug is not yet approved and remains in clinical development.
Ixmyelocel-T is being developed by Vericel Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol VCEL. Vericel is responsible for the clinical development and manufacturing of this investigational cell therapy for cardiovascular and bone-related conditions.
Ixmyelocel-T has completed Phase 2 and Phase 3 clinical trials. The most advanced study, NCT00505219, was a Phase 3 trial for osteonecrosis of the femoral head. Other trials were Phase 2 studies for dilated cardiomyopathy and ischemic dilated cardiomyopathy. All trials are completed, and the drug remains investigational.
Ixmyelocel-T has been studied in four completed clinical trials. NCT00505219 was a Phase 3 trial for osteonecrosis with 11 patients. NCT00765518 and NCT01020968 were Phase 2 trials for dilated cardiomyopathy with 40 and 22 patients, respectively. NCT01670981 was a Phase 2 trial for ischemic dilated cardiomyopathy with 114 patients.
Ixmyelocel-T is a cell therapy derived from a patient's own bone marrow. It is designed to promote tissue repair and regeneration by delivering a mixture of cells, including mesenchymal and hematopoietic stem cells, to damaged areas. This mechanism aims to improve blood flow and cardiac function in conditions like dilated cardiomyopathy and critical limb ischemia.
Ixmyelocel-T was formerly known as Cardiac Repair Cell (CRC) treatment. Clinical trial titles for NCT00765518 and NCT01020968 refer to it as 'Formerly Cardiac Repair Cell [CRC] Treatment,' indicating the name change. The drug is also referred to as catheter-based cardiac repair cell in some studies.