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Ixmyelocel-T · RESTORE-CLI

Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

Ensayo de Vericel Corp en Peripheral Arterial Disease (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

86

previstos

Centros

20

Fin del objetivo primario

mar 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en abr 2007.

Qué mide

Safety of TRCs in patients with CLI(key safety parameters include vital signs, physical exams, laboratory results, assessment of aspiration and injection sites, adverse events, major amputations, wounds presence(size and grading using the Wagner scale) (throughout trial) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia. The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.

Más ensayos de VCEL

Todos los de VCEL, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00468000), actualizada en may 2020.