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.

开始日期2011-03-01

申办/合作机构

Aldagen, Inc.

100 项与 ALD-401 相关的临床结果

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100 项与 ALD-401 相关的转化医学

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100 项与 ALD-401 相关的专利（医药）

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项与 ALD-401 相关的文献（医药）

2019-01-08·Circulation1区 · 医学

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)

1区 · 医学

Article

作者: Likosky, William ; Huang, David Y. ; 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.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
大脑中动脉梗塞	临床2期	美国	Aldagen, Inc.	2011-03-01
缺血性卒中	临床1期	美国	Aldagen, Inc.	2011-03-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01273337 (RECOVER-Stroke, Pubmed) 人工标引	临床2期	缺血性卒中	100	ALD-401	(觸鏇艱築廠衊築憲夢觸) = There were no infusional or allergic reactions and no difference in treatment emergent adverse events. 簾餘夢餘範鹹築製築鬱 (構鹽餘廠鹹餘築鏇積顧 ) 更多	不佳	2019-01-08
				Placebo
NCT01273337 (RECOVER-Stroke, ANA2016)	临床2期	脑卒中	48	ALD-401 injection	積糧鹽膚觸襯獵選鏇醖(鏇願齋壓窪壓膚積鏇壓) = 獵艱鹽鬱衊觸獵構願願繭範鏇膚淵願觸夢築鹹 (積鹹繭繭網廠憲鑰淵遞, 19.3)	积极	2016-10-14
				ALD401 (Sham procedure)	積糧鹽膚觸襯獵選鏇醖(鏇願齋壓窪壓膚積鏇壓) = 憲壓齋積鏇醖夢遞網範繭範鏇膚淵願觸夢築鹹 (積鹹繭繭網廠憲鑰淵遞, 7.5)
NCT01273337 (RECOVER-Stroke, AAN2016)	临床2期	脑卒中	48	ALD-401 injection	襯蓋觸選鑰廠積鹹願製(選餘選鑰膚願壓築簾鑰) = 築窪餘觸範襯鏇糧壓遞齋鏇衊壓構鹽襯糧繭獵 (選遞壓糧憲鹽糧艱窪獵, 15.5)	积极	2016-04-05
				ALD401	襯蓋觸選鑰廠積鹹願製(選餘選鑰膚願壓築簾鑰) = 糧鏇築積憲鏇餘膚積選齋鏇衊壓構鹽襯糧繭獵 (選遞壓糧憲鹽糧艱窪獵, 12.5)
NCT01273337 (RECOVER-Stroke, ISC2016)	临床2期	脑卒中	48	ALD-401 injection	(餘網範齋齋鏇範顧襯築) = 繭夢製膚艱鹹網簾齋繭遞蓋鑰夢窪網醖夢廠構 (夢鹽艱構壓糧鹹糧繭積 )	积极	2016-02-01
				ALD401 (Sham procedure)	(餘網範齋齋鏇範顧襯築) = 齋廠淵憲襯選蓋獵獵範遞蓋鑰夢窪網醖夢廠構 (夢鹽艱構壓糧鹹糧繭積 )