Drug intelligence / Profile preview

ALD-451

Development stage
Phase 1
Lead developer
Nuo Therapeutics
Modality
Stem Cell Therapies → Cell Therapies
Administration
Intravenous
01

Overview

ALD-451 is an autologous stem cell therapy being developed for potential treatment of neurological conditions. It consists of a specific population of bone marrow-derived adult stem cells that express high levels of the cytosolic enzyme aldehyde dehydrogenase (ALDH)[1][3]. ## Development and Mechanism ALD-451 contains pluripotent bone marrow-derived stem cells that are harvested from a patient's own body (autologous)[1][2]. These cells are characterized by their high expression of aldehyde dehydrogenase, which is why they're referred to as "ALDHbr" (ALDH-bright) cells[1]. The therapy appears to work by stimulating ALDH2 (Aldehyde dehydrogenase 2), though the exact mechanism of action in treating neurological conditions isn't fully detailed in the available information[3]. ## Clinical Development ALD-451 has been investigated in a Phase 1 clinical trial (NCT01639612) for WHO Grade IV malignant glioma patients following surgery, radiation therapy, and temozolomide treatment[3]. This pilot safety study aimed to: 1. Demonstrate the safety of intravenously administered autologous ALD-451 cells 2. Determine the recovery of ALD-451 from bone marrow of patients following radiation therapy and temozolomide 3. Explore whether ALD-451 administration may affect subsequent deterioration of neurocognition and patient-reported outcomes[3] ## Corporate History The therapy was originally developed by Nuo Therapeutics, Inc. (formerly known as Cytomedix)[2][3]. Duke University appears to have been involved in the clinical research of this therapy[3]. As of January 2025, the development status of ALD-451 appears to be in Phase 1 clinical trials, specifically for glioma[3].

02

Targets

ALDH2 (Mitochondrial Aldehyde Dehydrogenase)

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