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On September 8, Ixaka announced that its ongoing autologous multi-cell therapy (MCT) REX-001 has achieved positive interim results in a phase 3 clinical trial
.
The trial evaluated the safety and effectiveness of EX-001 compared with placebo in treating diabetic patients with chronic limb threat ischemia (CLTI)
REX-001 is an MCT product in the clinical development stage.
It is a human bone marrow-derived cell suspension rich in monocytes, granulocytes and CD34 positive cells
.
It uses cells extracted from the patient’s own bone marrow, enriches leukocytes, and then re-transfusions them back into the affected limb, so that a variety of immune and progenitor cells can be directly delivered to the diseased blood vessel to solve the complex disease process that leads to the clinical progress of CLTI, such as Plaque deposition, inflammation, ischemia, vascular degeneration, and ulcer formation
In this randomized, double-blind, placebo-controlled phase 3 trial, the primary endpoint is complete healing of the ulcer
.
After 12 months of treatment with REX-001, an interim analysis of the first 30% of patients enrolled was consistent with the hypothesis that REX-001 is an effective and safe CLTI therapy
Note: The original text has been deleted
Reference materials:
[1] Ixaka announces positive interim Phase 3 clinical trial data for its lead cell therapy candidate REX-001.
