A Phase 2 Randomized, Sham-Controlled Trial of Internal Carotid Artery Infusion of Autologous Bone Marrow–Derived ALD-401 Cells in Patients With Recent Stable Ischemic Stroke (RECOVER-Stroke) | Zendy

Sean I. Savitz | Zendy; Dileep R. Yavagal | Zendy; George Rappard | Zendy; William Likosky | Zendy; Neal Rutledge | Zendy; Carmelo Graffagnino | Zendy; Yazan J. Alderazi | Zendy; Jennifer A. Elder | Zendy; Peng R. Chen | Zendy; Ronald F. Budzik | Zendy; R Tarrel | Zendy; David Huang | Zendy; James M. Hinson | Zendy

Open Access

A Phase 2 Randomized, Sham-Controlled Trial of Internal Carotid Artery Infusion of Autologous Bone Marrow–Derived ALD-401 Cells in Patients With Recent Stable Ischemic Stroke (RECOVER-Stroke)

Author(s) -

Sean I. Savitz,

Dileep R. Yavagal,

George Rappard,

William Likosky,

Neal Rutledge,

Carmelo Graffagnino,

Yazan J. Alderazi,

Jennifer A. Elder,

Peng R. Chen,

Ronald F. Budzik,

R Tarrel,

David Huang,

James M. Hinson

Publication year - 2019

Publication title -

circulation

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 7.795

H-Index - 607

eISSN - 1524-4539

pISSN - 0009-7322

DOI - 10.1161/circulationaha.117.030659

Subject(s) - medicine , modified rankin scale , stroke (engine) , adverse effect , clinical endpoint , randomized controlled trial , population , asymptomatic , quality of life (healthcare) , surgery , anesthesia , ischemia , ischemic stroke , mechanical engineering , environmental health , engineering , nursing

Ischemic stroke has no approved treatments to enhance recovery. ALD-401 is an enriched population of aldehyde dehydrogenase-bright stem cells, capable of reducing neurological deficits in animal models. The primary objective of this trial was to determine the safety of internal carotid artery, intra-arterially delivered autologous bone marrow-derived ALD-401 in patients with disabling middle cerebral artery stroke in comparison with sham harvest with sham infusion. Secondary objectives were to determine feasibility and efficacy.

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