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news.The US Food and Drug Administration (FDA) has cleared Aldagen's investigational new drug (IND) application to conduct a clinical trial using Aldagen's ALD-401 for the treatment of stroke patients.
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ALD-401 is the population of stem cells produced using Aldagen’s proprietary technology to sort a specified quantity of bone marrow collected from the patient receiving the therapy. Preclinical research suggests that these stem cells may promote the repair of ischemic tissue damage.
The Phase 2 trial is designed to investigate the safety of ALD-401 and its potential efficacy to improve clinical outcomes in patients with ischemic strokes when administered 13 and 19 days after the stroke.
The company expects to recruit around 100 patients in the trial.
Aldagen CEO Lyle Hohnke said that ALD-401 will be delivered about two weeks after a stroke and therefore has the potential to treat a large group of patients who have no therapeutic options.