NCT04631406 is a Phase 1, PHASE2 clinical trial of Neural Stem Cells in Ischemic Stroke, sponsored by Gary Steinberg, MD, PhD.

Who is sponsoring NCT04631406?

NCT04631406 is sponsored by Gary Steinberg, MD, PhD.

What drugs are being tested in NCT04631406?

Interventions in NCT04631406: Neural Stem Cells.

What condition does NCT04631406 study?

NCT04631406 studies Ischemic Stroke.

Is NCT04631406 still recruiting?

NCT04631406 is currently active, enrolled. Last updated 20 March 2025.

Last reviewed 2025-03-20 · How we verify

NCT04631406

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)

Active, enrolled Phase 1, PHASE2 Last updated 20 March 2025

What this trial tests

Phase 1, PHASE2 trial testing Neural Stem Cells in Ischemic Stroke in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 January 2021

Primary endpoint
31 August 2025

31 August 2029

Quick facts

Lead sponsor	Gary Steinberg, MD, PhD
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	4 January 2021
Primary completion	31 August 2025
Estimated completion	31 August 2029
Sites	1 location across United States

Drugs / interventions tested

Neural Stem Cells — full drug profile →

Conditions studied

Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Gary Steinberg, MD, PhD — full company profile →

Who can join

Adults 18 to 75, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke.

Publications & conference data

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

Understanding the Pathophysiology of Ischemic Stroke: The Basis of Current Therapies and Opportunity for New Ones.
Salaudeen MA, Bello N, Danraka RN, Ammani ML. · · 2024 · cited 89× · PMID 38540725 · DOI 10.3390/biom14030305
Advancements in Human Embryonic Stem Cell Research: Clinical Applications and Ethical Issues.
Park SJ, Kim YY, Han JY, Kim SW, et al · · 2024 · cited 29× · PMID 38502279 · DOI 10.1007/s13770-024-00627-3
Human Neural Stem Cells for Cell-Based Medicinal Products.
Fernandez-Muñoz B, Garcia-Delgado AB, Arribas-Arribas B, Sanchez-Pernaute R. · · 2021 · cited 24× · PMID 34572024 · DOI 10.3390/cells10092377
Emerging strategies for nerve repair and regeneration in ischemic stroke: neural stem cell therapy.
Wang S, He Q, Qu Y, Yin W, et al · · 2024 · cited 22× · PMID 38526280 · DOI 10.4103/1673-5374.391313
Stem Cell- and Cell-Based Therapies for Ischemic Stroke.
Nistor-Cseppentö DC, Jurcău MC, Jurcău A, Andronie-Cioară FL, et al · · 2022 · cited 17× · PMID 36421118 · DOI 10.3390/bioengineering9110717
Mechanism of inflammatory response and therapeutic effects of stem cells in ischemic stroke: current evidence and future perspectives.
Wang Y, Yuan T, Lyu T, Zhang L, et al · · 2025 · cited 16× · PMID 38767477 · DOI 10.4103/1673-5374.393104
Sustaining Brain Youth by Neural Stem Cells: Physiological and Therapeutic Perspectives.
Santos M, Moreira JAF, Santos SS, Solá S. · · 2025 · cited 2× · PMID 39985708 · DOI 10.1007/s12035-025-04774-z
Cell therapy for stroke and spinal cord injury in clinical trials.
Fan Y, Wong ST, Goh ELK, Chan JKY. · · 2026 · PMID 41641797 · DOI 10.1093/stcltm/szaf082

Verify or expand the search:

Other recruiting trials for Ischemic Stroke

Currently open trials in the same condition.

NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · recruiting
NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · recruiting
NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · Phase 2 · recruiting
NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke · recruiting
NCT07371455 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04631406 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gary Steinberg, MD, PhD
Last refreshed: 20 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04631406.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing