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NCT04873752
A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
Phase 1, PHASE2 trial testing UDI-001 in Cerebral Palsy in 6 participants. Completed in 15 February 2024.
12 July 2023
Quick facts
| Lead sponsor | Rohto Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 2 June 2021 |
| Primary completion | 12 July 2023 |
| Estimated completion | 15 February 2024 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- UDI-001 — full drug profile →
Conditions studied
- Cerebral Palsy — all drugs for Cerebral Palsy →
- Periventricular Leukomalacia — all drugs for Periventricular Leukomalacia →
Sponsor
Rohto Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 12 Months to 24 Months, any sex, with Cerebral Palsy or Periventricular Leukomalacia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Mesenchymal Stromal/Stem Cell Extracellular Vesicles and Perinatal Injury: One Formula for Many Diseases.
Delavogia E, Ntentakis DP, Cortinas JA, Fernandez-Gonzalez A, et al · · 2022 · cited 12× · PMID 36044737 · DOI 10.1093/stmcls/sxac062
Verify or expand the search:
- PubMed search for NCT04873752
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Rohto Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT04888949 — A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19) · Phase 2 · completed
- NCT04522986 — An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection · Phase 1 · completed
- NCT03472742 — An Follow-Up Study of Liver Cirrhosis · completed
- NCT03254758 — A Study of ADR-001 in Patients With Liver Cirrhosis · Phase 1, PHASE2 · completed
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 NCT04873752 (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 Rohto Pharmaceutical Co., Ltd.
- Last refreshed: 6 April 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/NCT04873752.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing