NCT03214146 is a Phase 1 clinical trial of HYNRCS-Allo inj in Amyotrophic Lateral Sclerosis, sponsored by Hanyang University Seoul Hospital.

Who is sponsoring NCT03214146?

NCT03214146 is sponsored by Hanyang University Seoul Hospital.

What drugs are being tested in NCT03214146?

Interventions in NCT03214146: HYNRCS-Allo inj.

What condition does NCT03214146 study?

NCT03214146 studies Amyotrophic Lateral Sclerosis.

Is NCT03214146 still recruiting?

NCT03214146 is currently status unknown. Last updated 14 May 2019.

Last reviewed 2019-05-14 · How we verify

NCT03214146

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

An Open-label, Phase 1 Trial for Safety and Efficacy Study of 2nd Cycle Treatment After 6 Months of 1st Cycle HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell("HYNR-CS-Allo Inj") Treatment in Amyotrophic Lateral Sclerosis(ALS)

Status unknown Phase 1 Last updated 14 May 2019

What this trial tests

Phase 1 trial testing HYNRCS-Allo inj in Amyotrophic Lateral Sclerosis in 6 participants. Status unknown.

Timeline

1 February 2017

Primary endpoint
25 March 2019

1 October 2021

Quick facts

Lead sponsor	Hanyang University Seoul Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	1 February 2017
Primary completion	25 March 2019
Estimated completion	1 October 2021
Sites	1 location across South Korea

Drugs / interventions tested

HYNRCS-Allo inj — full drug profile →

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Hanyang University Seoul Hospital

Who can join

Adults 25 to 80, any sex, with Amyotrophic Lateral Sclerosis. 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.

The Incidence of any treatment related serious adverse events(SAE)
Time frame: 12 months

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNRCS-Allo-ALS-02 inj"), through intrathecal delivery for the repeated treatment after 6 months of first treatment in patients with amyotrophic lateral sclerosis(ALS). This study is an open label, single-dose study to assess the safety and efficacy of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNRCS-Allo-ALS-02 inj")

Publications & conference data

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

Neuroprotective Potential of Cell-Based Therapies in ALS: From Bench to Bedside.
Forostyak S, Sykova E. · · 2017 · cited 17× · PMID 29114200 · DOI 10.3389/fnins.2017.00591
Two in One: Use of Divalent Manganese Ions as Both Cross-Linking and MRI Contrast Agent for Intrathecal Injection of Hydrogel-Embedded Stem Cells.
Kalkowski L, Golubczyk D, Kwiatkowska J, Holak P, et al · · 2021 · cited 7× · PMID 34371767 · DOI 10.3390/pharmaceutics13071076
Underregistration and Underreporting of Stem Cell Clinical Trials in Neurological Disorders.
Lee TE, Kim A, Jang M, Jeon B. · · 2018 · cited 4× · PMID 29629526 · DOI 10.3988/jcn.2018.14.2.215

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

NCT07502677 — Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Scle · recruiting
NCT07478172 — Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease · NA · recruiting
NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting

Other Hanyang University Seoul Hospital trials

Trials by the same sponsor.

NCT06144021 — Efficacy and Safety of Kefir Whey Postbiotics · NA · recruiting
NCT06429644 — Long-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations · completed
NCT05164198 — REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST) · Phase 4 · unknown
NCT04871945 — Protective Antibody Level After COVID-19 Vaccination Among Patients Under Hemodialysis · completed
NCT04567134 — Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea · unknown

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 NCT03214146 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Hanyang University Seoul Hospital
Last refreshed: 14 May 2019

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/NCT03214146.

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