Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed by Vericel Corporation. It has been studied in cardiovascular and related conditions including critical limb ischemia, dilated cardiomyopathy, ischemic dilated cardiomyopathy, osteonecrosis, and peripheral arterial disease. It is not an approved medicine and remains in clinical development.
Ixmyelocel-T has been studied for critical limb ischemia, dilated cardiomyopathy, ischemic dilated cardiomyopathy, osteonecrosis, and peripheral arterial disease. It is an investigational cell therapy, so it is not an approved treatment for any of these conditions. All clinical programs to date have been completed.
Ixmyelocel-T is developed by Vericel Corporation, which trades on the Nasdaq under the ticker VCEL. Vericel is the sponsor of the clinical trials evaluating the therapy in critical limb ischemia and dilated cardiomyopathy.
Ixmyelocel-T has reached Phase 3 in critical limb ischemia, while its heart failure programs in dilated cardiomyopathy and ischemic dilated cardiomyopathy were Phase 2. The drug is investigational and has not been approved by the FDA. All listed trials are completed, and no trials are currently active.
Ixmyelocel-T has been evaluated in completed trials including NCT01483898 in critical limb ischemia, NCT01670981 in ischemic dilated cardiomyopathy, NCT01020968 in dilated cardiomyopathy, and NCT00765518, also known as IMPACT-DCM, in dilated cardiomyopathy. These studies enrolled a combined total of 114 participants across the United States and Canada.
Yes. Ixmyelocel-T was formerly called Catheter-based Cardiac Repair Cell, or CRC. The earlier name appears in the titles of the dilated cardiomyopathy trials NCT01020968 and NCT00765518, which studied the same cell therapy before the current name was adopted.