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NCT02452723
A Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's Disease
Phase 1 trial testing ISC-hpNSC in Parkinson Disease in 12 participants. Completed in 1 September 2025.
18 June 2025
Quick facts
| Lead sponsor | Cyto Therapeutics Pty Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 July 2016 |
| Primary completion | 18 June 2025 |
| Estimated completion | 1 September 2025 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- ISC-hpNSC — full drug profile →
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
Sponsor
Cyto Therapeutics Pty Limited — full company profile →
Who can join
Adults 30 to 70, any sex, with Parkinson Disease. 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.
-
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, related TEAEs, severe TEAEs
Time frame: 12 month
Sponsor's own description
This study will evaluate the safety of an investigational cell transplantation therapy, ISC-hpNSC, in patients with Parkinson's disease. All patients will receive the therapy, which consists of human neural stem cells. Three dose levels will be examined in the study.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Signaling pathways in Parkinson's disease: molecular mechanisms and therapeutic interventions.
Dong-Chen X, Yong C, Yang X, Chen-Yu S, et al · · 2023 · cited 258× · PMID 36810524 · DOI 10.1038/s41392-023-01353-3 -
Pre-clinical study of induced pluripotent stem cell-derived dopaminergic progenitor cells for Parkinson's disease.
Doi D, Magotani H, Kikuchi T, Ikeda M, et al · · 2020 · cited 257× · PMID 32632153 · DOI 10.1038/s41467-020-17165-w -
Pluripotent Stem Cells: Current Understanding and Future Directions.
Romito A, Cobellis G. · · 2016 · cited 130× · PMID 26798367 · DOI 10.1155/2016/9451492 -
iPS cell-based therapy for Parkinson's disease: A Kyoto trial.
Takahashi J. · · 2020 · cited 129× · PMID 33490319 · DOI 10.1016/j.reth.2020.06.002 -
Cell therapies in the clinic.
Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214 -
Therapeutic Plasticity of Neural Stem Cells.
Ottoboni L, von Wunster B, Martino G. · · 2020 · cited 69× · PMID 32265815 · DOI 10.3389/fneur.2020.00148 -
Emerging Therapeutic Strategies for Parkinson's Disease and Future Prospects: A 2021 Update.
Gouda NA, Elkamhawy A, Cho J. · · 2022 · cited 57× · PMID 35203580 · DOI 10.3390/biomedicines10020371 -
Stem Cell-Based Therapies for Parkinson Disease.
Liu Z, Cheung HH. · · 2020 · cited 55× · PMID 33137927 · DOI 10.3390/ijms21218060
Verify or expand the search:
- PubMed search for NCT02452723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02452723 (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 Cyto Therapeutics Pty Limited
- Last refreshed: 16 January 2026
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/NCT02452723.
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