NCT01363401 is a Phase 1/Phase 2 clinical trial of HYNR-CS inj in Amyotrophic Lateral Sclerosis, sponsored by Corestemchemon, Inc..

Who is sponsoring NCT01363401?

NCT01363401 is sponsored by Corestemchemon, Inc..

What drugs are being tested in NCT01363401?

Interventions in NCT01363401: HYNR-CS inj, Control group.

What condition does NCT01363401 study?

NCT01363401 studies Amyotrophic Lateral Sclerosis, ALS.

Is NCT01363401 still recruiting?

NCT01363401 is currently completed. Last updated 15 March 2022.

Are results published for NCT01363401?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-15 · How we verify

NCT01363401

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

An Open-label, Phase I/II Trial for Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis

Completed Phase 1/Phase 2 Results posted Last updated 15 March 2022

What this trial tests

Phase 1/Phase 2 trial testing HYNR-CS inj in Amyotrophic Lateral Sclerosis in 72 participants. Completed in 1 August 2013.

Timeline

1 February 2011

Primary endpoint
1 May 2013

1 August 2013

Quick facts

Lead sponsor	Corestemchemon, Inc.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	1 February 2011
Primary completion	1 May 2013
Estimated completion	1 August 2013
Sites	1 location across South Korea

Drugs / interventions tested

HYNR-CS inj — full drug profile →
Control group — full drug profile →

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
ALS — all drugs for ALS →

Sponsor

Corestemchemon, Inc. — full company profile →

Who can join

Adults 25 to 75, any sex, with Amyotrophic Lateral Sclerosis or ALS. 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 Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Between Treatment Groups and Control Groups.
Time frame: baseline(Visit 5) and week 16(Visit 9)
ALSFRS-R is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. ALSFRS-R was evaluated at baseline and week 28.(The first injection was performed at 0 week) ALSFRS-R total score variation baseline(Visit 5) and week 16(Visit 9)

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells("HYNR-CS inj"), through intrathecal delivery for the treatment in patients with ALS. This study consists of 2 steps. First step is a safety study of the intrathecal(IT) injection of "HYNR-CS inj" in 8 patients with ALS. In this phase 1 study, AE, laboratory test, physical examination, vital signs, Electrocardiogram, and Chest X-Ray examination were evaluated in terms of safety. Second step is to compare the efficacy and safety between test group and control group of total 64 patients with ALS.

Publications & conference data

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

Mechanisms underlying the protective effects of mesenchymal stem cell-based therapy.
Fan XL, Zhang Y, Li X, Fu QL. · · 2020 · cited 381× · PMID 31965214 · DOI 10.1007/s00018-020-03454-6
Clinical application of mesenchymal stem cell in regenerative medicine: a narrative review.
Margiana R, Margiana R, Margiana R, Markov A, et al · · 2022 · cited 263× · PMID 35902958 · DOI 10.1186/s13287-022-03054-0
Phase I trial of repeated intrathecal autologous bone marrow-derived mesenchymal stromal cells in amyotrophic lateral sclerosis.
Oh KW, Moon C, Kim HY, Oh SI, et al · · 2015 · cited 131× · PMID 25934946 · DOI 10.5966/sctm.2014-0212
Repeated Intrathecal Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis.
Oh KW, Noh MY, Kwon MS, Kim HY, et al · · 2018 · cited 92× · PMID 30048006 · DOI 10.1002/ana.25302
Current State and Future Directions in the Therapy of ALS.
Tzeplaeff L, Wilfling S, Requardt MV, Herdick M. · · 2023 · cited 87× · PMID 37296644 · DOI 10.3390/cells12111523
Rising Stars: Astrocytes as a Therapeutic Target for ALS Disease.
Izrael M, Slutsky SG, Revel M. · · 2020 · cited 58× · PMID 32848579 · DOI 10.3389/fnins.2020.00824
A perspective on therapies for amyotrophic lateral sclerosis: can disease progression be curbed?
Xu X, Shen D, Gao Y, Zhou Q, et al · · 2021 · cited 49× · PMID 34372914 · DOI 10.1186/s40035-021-00250-5
Advances, challenges and future directions for stem cell therapy in amyotrophic lateral sclerosis.
Ciervo Y, Ning K, Ning K, Jun X, et al · · 2017 · cited 47× · PMID 29132389 · DOI 10.1186/s13024-017-0227-3

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 Corestemchemon, Inc. trials

Trials by the same sponsor.

NCT06676423 — Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS · Phase 1 · completed
NCT04745299 — Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients with ALS · Phase 3 · active not recruiting
NCT04495582 — Long-term Follow-up of Phase 1 Clinical Trial of CS10BR05(CS10BR05-MSA101) · completed
NCT03265444 — Safety and Tolerability of CS10BR05 Inj. in Subjects with Multiple System Atrophy · Phase 1 · completed
NCT04522505 — Long-term Follow-up for Evaluating the Safety of CS20AT04 in Subject with Lupus Nephritis · completed

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 NCT01363401 (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 Corestemchemon, Inc.
Last refreshed: 15 March 2022

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/NCT01363401.

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