NCT01273337

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

Status unknown Phase 2 Last updated 14 January 2014

What this trial tests

Phase 2 trial testing ALD-401 in Stroke in 100 participants. Status unknown.

Timeline

1 March 2011

Primary endpoint
1 July 2014

1 January 2015

Quick facts

Lead sponsor	Aldagen
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	1 March 2011
Primary completion	1 July 2014
Estimated completion	1 January 2015
Sites	9 locations across United States

Drugs / interventions tested

• ALD-401 — full drug profile →
• Sham Procedure — full drug profile →

Conditions studied

• Stroke — all drugs for Stroke →
• Ischemic Stroke — all drugs for Ischemic Stroke →
• Stroke in Middle Cerebral Artery (MCA) — all drugs for Stroke in Middle Cerebral Artery (MCA) →

Sponsor

Aldagen — full company profile →

Who can join

Adults 30 to 83, any sex, with Stroke or Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety of Delivery of ALD-401
  Time frame: 1 year
  The safety of the delivery of ALD-401 will be assessed by the following: * Frequency and proportion of severe adverse events, * Physical and clinical laboratory testing, * Radiological worsening as detected by MRI (evidence of hemorrhage) with and without clinical symptoms, * MRI evidence of new heterotopias, tumors, or vascular malformations over 12 months * Increase of NIHSS by ≥ 4 pts within 2

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell based therapies for ischemic stroke: from basic science to bedside.
   Liu X, Ye R, Yan T, Yu SP, et al · · 2014 · cited 138× · PMID 24333397 · DOI 10.1016/j.pneurobio.2013.11.007
2. 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).
   Savitz SI, Yavagal D, Rappard G, Likosky W, et al · · 2019 · cited 102× · PMID 30586746 · DOI 10.1161/circulationaha.117.030659
3. Brain repair: cell therapy in stroke.
   Kalladka D, Muir KW. · · 2014 · cited 71× · PMID 24627643 · DOI 10.2147/sccaa.s38003
4. The rise of cell therapy trials for stroke: review of published and registered studies.
   Rosado-de-Castro PH, Pimentel-Coelho PM, da Fonseca LM, de Freitas GR, et al · · 2013 · cited 52× · PMID 23509917 · DOI 10.1089/scd.2013.0089
5. Stem cell therapy for acute cerebral injury: what do we know and what will the future bring?
   Lemmens R, Steinberg GK. · · 2013 · cited 43× · PMID 24136128 · DOI 10.1097/wco.0000000000000023
6. The potential benefit of stem cell therapy after stroke: an update.
   Banerjee S, Williamson DA, Habib N, Chataway J. · · 2012 · cited 43× · PMID 23091389 · DOI 10.2147/vhrm.s25745
7. Taking central nervous system regenerative therapies to the clinic: curing rodents <i>versus</i> nonhuman primates <i>versus</i> humans.
   Tsintou M, Dalamagkas K, Makris N. · · 2020 · cited 26× · PMID 31571651 · DOI 10.4103/1673-5374.266048
8. Cell Therapy of Stroke: Do the Intra-Arterially Transplanted Mesenchymal Stem Cells Cross the Blood-Brain Barrier?
   Yarygin KN, Namestnikova DD, Sukhinich KK, Gubskiy IL, et al · · 2021 · cited 19× · PMID 34831220 · DOI 10.3390/cells10112997