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IND approval for PII Stem Cell Trial for Stroke, Aldargen

The FDA has accepted Aldargen’s IND application to start phase II clinical trials  for stroke patients.
  • The clinical trial will test the use of ALD-401’s collection of stem cells as a treatment for stroke victims;
  • The 100 or so participants in the clinical trial will receive an injection of ALD-401 stem cells 13 to 19 days after suffering a stroke;
  •  The trial will test the ability of the stem cell therapy to alleviate stroke damage;
  • ALD-401 can be delivered about 2 weeks after a stroke and therefore has the potential to treat a large group of patients who have no therapeutic options.

Stroke represents the leading cause of disability in the US and the third leading cause of morbidity.  

  • The only product currently available for stroke treatment is an anti-clotting agent that must be administered within 3 hours of onset of the stroke;
  • Because of this timing requirement, less than 5% of stroke patients receive the treatment.

Aldargen, a Durham, NC drug developer has had an $81M initial public offering pending since fall 2009.