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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

Completed Phase 1 Last updated 16 January 2026
What this trial tests

Phase 1 trial testing ISC-hpNSC in Parkinson Disease in 12 participants. Completed in 1 September 2025.

Timeline
1 July 2016
Primary endpoint
18 June 2025
1 September 2025

Quick facts

Lead sponsorCyto Therapeutics Pty Limited
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date1 July 2016
Primary completion18 June 2025
Estimated completion1 September 2025
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

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.

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):

  1. 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
  2. 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
  3. Pluripotent Stem Cells: Current Understanding and Future Directions.
    Romito A, Cobellis G. · · 2016 · cited 130× · PMID 26798367 · DOI 10.1155/2016/9451492
  4. 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
  5. 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
  6. Therapeutic Plasticity of Neural Stem Cells.
    Ottoboni L, von Wunster B, Martino G. · · 2020 · cited 69× · PMID 32265815 · DOI 10.3389/fneur.2020.00148
  7. 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
  8. Stem Cell-Based Therapies for Parkinson Disease.
    Liu Z, Cheung HH. · · 2020 · cited 55× · PMID 33137927 · DOI 10.3390/ijms21218060

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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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