NCT06145711: hiPSC-DAP

A Clinical Trial of Parkinson's Disease Treatment by HiPSCs Derived Dopaminergic Neural Precursor Cells

Recruiting now NA Last updated 15 October 2024

What this trial tests

NA trial testing hiPSC-DAP in Parkinson's Disease in 3 participants. Currently enrolling.

Timeline

23 November 2023

Primary endpoint
22 December 2025

22 December 2025

Quick facts

Lead sponsor	Shanghai East Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	23 November 2023
Primary completion	22 December 2025
Estimated completion	22 December 2025
Sites	2 locations across China

Drugs / interventions tested

• hiPSC-DAP

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

Shanghai East Hospital

Who can join

Adults 30 to 70, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

XellSmart Biomedical (Suzhou) Co., Ltd. has closely collaborated with Shanghai East Hospital(East Hospital Affiliated To Tongji University) , using iPSC seed cells, on the development and establishment of a dopaminergic neural precursor cell production system.

This study is conducted under collaboration between Shanghai East Hospital and XellSmart Biomedical (Suzhou) Co., Ltd. It is a distinctive stem cell therapy research targeting Parkinson's disease patients, characterized by the following:

1. The first instance in China of using autologous iPSC-derived subtype-specific dopaminergic neural precursor cells for alternative transplantation therapy in Parkinson's disease.
2. Before the initiation of this study, there was only one reported case around the world involving the use of laboratory-grade autologous iPSC-induced dopaminergic neural precursor cells for Parkinson's disease treatment in an American Caucasian individual. Positive preliminary clinical research results were obtained and published in the New England Journal of Medicine in 2020. Since then, no similar studies have been reported.

It has great significance to conduct this research. It will fill two critical clinical research gaps in stem cell therapy for Parkinson's disease in the world:

1. The use of clinical-grade autologous iPSCs differentiated into dopaminergic neural cells, and treat Parkinson's disease.
2. Evaluating the safety of using autologous iPSC-differentiated dopaminergic neural cells for Parkinson's disease treatment in individuals of Asian descent or Chinese ethnicity.

Publications & conference data

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

1. Induced pluripotent stem cells (iPSCs): molecular mechanisms of induction and applications.
   Cerneckis J, Cai H, Shi Y. · · 2024 · cited 248× · PMID 38670977 · DOI 10.1038/s41392-024-01809-0
2. Stem cell therapeutics and gene therapy for neurologic disorders.
   Chen KS, Koubek EJ, Sakowski SA, Feldman EL. · · 2024 · cited 26× · PMID 39096590 · DOI 10.1016/j.neurot.2024.e00427
3. Stem Cell Therapy, the Market, the Opportunities and the Threat.
   Bahari M, Mokhtari H, Yeganeh F. · · 2023 · cited 9× · PMID 38751658 · DOI 10.22088/ijmcm.bums.12.3.310
4. Induced Pluripotent (iPSC) and Mesenchymal (MSC) Stem Cells for In Vitro Disease Modeling and Regenerative Medicine.
   Panferov E, Dodina M, Reshetnikov V, Ryapolova A, et al · · 2025 · cited 8× · PMID 40565081 · DOI 10.3390/ijms26125617
5. Controversies and insights into PTBP1-related astrocyte-neuron transdifferentiation: neuronal regeneration strategies for Parkinson's and Alzheimer's disease.
   McDowall S, Bagda V, Hodgetts S, Mastaglia F, et al · · 2024 · cited 6× · PMID 39627843 · DOI 10.1186/s40035-024-00450-9
6. Stem cell extracellular vesicles: a new dawn for anti-inflammatory treatment of neurodegenerative diseases.
   Yu M, Ma H, Lai X, Wu J, et al · · 2025 · cited 5× · PMID 40717894 · DOI 10.3389/fnagi.2025.1592578
7. Unlocking the therapeutic potential: odyssey of induced pluripotent stem cells in precision cell therapies.
   Mohite P, Puri A, Dave R, Budar A, et al · · 2024 · cited 5× · PMID 38963728 · DOI 10.1097/js9.0000000000001892
8. Can pluripotent/multipotent stem cells reverse Parkinson's disease progression?
   Wu Y, Meng X, Cheng WY, Yan Z, et al · · 2024 · cited 5× · PMID 38356648 · DOI 10.3389/fnins.2024.1210447