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NCT06608719
Retrospective Study on the Safety and Therapeutic/Improvement Effects of Intravenous Administration of SHED-CM for ALS (SHED-CAH2023)
trial testing The study drug is SHED-CM manufactured by U-Factor in Amyotrophic Lateral Sclerosis in 24 participants. Completed in 1 July 2024.
1 July 2024
Quick facts
| Lead sponsor | Hitonowa Medical |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 24 |
| Start date | 25 December 2023 |
| Primary completion | 1 July 2024 |
| Estimated completion | 1 July 2024 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- The study drug is SHED-CM manufactured by U-Factor — full drug profile →
Conditions studied
- Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
Sponsor
Hitonowa Medical — full company profile →
Who can join
Adults 38 to 81, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, we will retrospectively evaluate the safety and efficacy of administering SHED-CM for the treatment of ALS.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A narrative review on the therapeutic potential of stem cells in neurodegenerative diseases: advances, insights, and challenges.
Patel T, Henna F, Sharif I, Javed I, et al · · 2026 · PMID 41675725 · DOI 10.1097/ms9.0000000000004490
Verify or expand the search:
- PubMed search for NCT06608719
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of The study drug is SHED-CM manufactured by U-Factor
Trials testing the same drug.
- NCT06889857 — Safety and Efficacy of Intravenous Administration of SHED-CM for ALS · EARLY_PHASE1 · active not recruiting
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 Hitonowa Medical trials
Trials by the same sponsor.
- NCT06889857 — Safety and Efficacy of Intravenous Administration of SHED-CM for ALS · EARLY_PHASE1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06608719 (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 Hitonowa Medical
- Last refreshed: 23 September 2024
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/NCT06608719.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing