NCT05094011

Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease

Not yet recruiting Phase 1 Last updated 21 November 2024

What this trial tests

Phase 1 trial testing Aadipose-Derived Mesenchymal Stem Cells in Idiopathic Parkinson's Disease in 9 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
30 September 2027

31 July 2028

Quick facts

Lead sponsor	Taiwan Mitochondrion Applied Technology Co., Ltd.
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	1 March 2026
Primary completion	30 September 2027
Estimated completion	31 July 2028

Drugs / interventions tested

• Aadipose-Derived Mesenchymal Stem Cells — full drug profile →

Conditions studied

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

Sponsor

Taiwan Mitochondrion Applied Technology Co., Ltd. — full company profile →

Who can join

Adults 45 to 70, any sex, with Idiopathic Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective: To assess the safety profile of autologous MitoCell administered to subjects with idiopathic Parkinson's disease (PD)

Secondary Objective: To explore the efficacy and safety of MitoCell given as the recommended dose by stereotactic intrastriatal implantation

Publications & conference data

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

1. Therapeutic utility of mesenchymal stromal cell (MSC)-based approaches in chronic neurodegeneration: a glimpse into underlying mechanisms, current status, and prospects.
   Rahbaran M, Zekiy AO, Bahramali M, Jahangir M, et al · · 2022 · cited 38× · PMID 35842587 · DOI 10.1186/s11658-022-00359-z
2. Mesenchymal stromal cell-derived secretome-based therapy for neurodegenerative diseases: overview of clinical trials.
   Ghasemi M, Roshandel E, Mohammadian M, Farhadihosseinabadi B, et al · · 2023 · cited 34× · PMID 37143147 · DOI 10.1186/s13287-023-03264-0
3. Neural Cells for Neurodegenerative Diseases in Clinical Trials.
   Fan Y, Goh ELK, Chan JKY. · · 2023 · cited 17× · PMID 37487111 · DOI 10.1093/stcltm/szad041
4. Current Status of Mesenchymal Stem/Stromal Cells for Treatment of Neurological Diseases.
   Soares MBP, Gonçalves RGJ, Vasques JF, da Silva-Junior AJ, et al · · 2022 · cited 16× · PMID 35782379 · DOI 10.3389/fnmol.2022.883378
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. LRRK2-mediated mitochondrial dysfunction in Parkinson's disease.
   Buck SA, Sanders LH. · · 2025 · cited 5× · PMID 40440058 · DOI 10.1042/bcj20253062
7. 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
8. Mesenchymal stem cells and the central nervous system: historical perspectives and future directions.
   Mazurek CY, Kaniuk JK, Ahuja CS. · · 2026 · PMID 41809632 · DOI 10.3389/fnmol.2026.1742864