A Phase 2 Randomized, Controlled Study With a Phase 1 Safety Cohort Testing ALD-401 Derived From Autologous Bone Marrow Delivered Via Intracarotid Infusion in Subjects With Ischemic Stroke With Blinded Assessments

The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by intracarotid infusion and to assess efficacy of treatment in subjects who have had unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA). ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the stroke.

Start Date01 Mar 2011

Sponsor / Collaborator

Aldagen, Inc.

100 Clinical Results associated with ALD-401

100 Translational Medicine associated with ALD-401

100 Patents (Medical) associated with ALD-401

Literatures (Medical) associated with ALD-401

08 Jan 2019·CirculationQ1 · MEDICINE

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)

Q1 · MEDICINE

Article

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

Background: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.Methods:This was a prospective phase 2, industry-funded, randomized, sham-controlled, parallel-group, multicenter study with blinded assessments. One hundred subjects were planned, aged 30 to 83 years, with confirmed first-time middle cerebral artery ischemic stroke with modified Rankin scale ≥3. Study patients were randomly assigned 3:2 to bone marrow harvest at 11 to 17 days after stroke followed 2 days later by intracarotid infusion of ALD-401 versus sham harvest and then sham infusion in the same timeframe. The primary study outcome was safety based on the incidence of a 4-point National Institutes of Health Stroke Scale worsening and the proportion of serious adverse events. Efficacy was based on modified Rankin scale change at 90 days. Other secondary outcomes were the proportions of patients experiencing adverse events, disability by Barthel Index, quality of life using EQ-5D, rehabilitation utilization, disability at 1 year, and MRI evidence of complications.Results: There were no infusional or allergic reactions and no difference in treatment emergent adverse events. Four patients had small areas of asymptomatic restricted diffusion on MRI in the treatment group. There was no significant difference between the ALD-401 and placebo groups on the modified Rankin scale for the intent-to-treat population at day 90 (mean difference, 0.3; 95% CI, –0.3 to 0.8; P =0.330). There were no significant differences between the groups on any of the secondary efficacy measures. Conclusions:Intracarotid infusion of ALD-401 does not lead to clinical adverse events in patients with subacute ischemic stroke, although there was a higher incidence of small lesions on MRI in the treatment group. There was no difference in the primary efficacy end point between the groups. The study provides a framework for the design and conduct of future intra-arterial cell therapy trials in stroke.Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01273337.

100 Deals associated with ALD-401

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Infarction, Middle Cerebral Artery	Phase 2	US	Aldagen, Inc.	01 Mar 2011
Ischemic stroke	Phase 2	US	Aldagen, Inc.	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01273337 (RECOVER-Stroke, Pubmed) Manual	Phase 2	Ischemic stroke	100	ALD-401	(frxvfmorvc) = There were no infusional or allergic reactions and no difference in treatment emergent adverse events. zqijpttogm (wlchyqzzhz ) View more	Negative	08 Jan 2019
				Placebo
RECOVER-Stroke (ANA2016)	Not Applicable	Stroke	48	ALD-401 injection	eahauuxmza(ashpddkxuy) = chtmgojvqz tihpplzrpf (nztpirhcdt, 19.3)	Positive	14 Oct 2016
				ALD401	eahauuxmza(ashpddkxuy) = fkliqdbuni tihpplzrpf (nztpirhcdt, 7.5)
RECOVER-Stroke (AAN2016)	Not Applicable	Stroke	48	ALD-401 injection	ohxmwoikyc(dhfedtcoqw) = pqzwzbqbmn gcfdevjcyf (lfbpeagrzi, 15.5)	Positive	05 Apr 2016
				ALD401	ohxmwoikyc(dhfedtcoqw) = zbhfcfyvhq gcfdevjcyf (lfbpeagrzi, 12.5)
RECOVER-Stroke (ISC2016)	Not Applicable	Stroke	48	ALD-401 injection	(ptgzsfmdod) = mfnxzreezn ucbrdfabfz (uybynwjxmc )	Positive	01 Feb 2016
				ALD401 (Sham procedure)	(ptgzsfmdod) = dpgxddgsjt ucbrdfabfz (uybynwjxmc )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

ALD-401

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation