NCT06583291

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that iDAP has on Parkinson's disease (PD) patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1 parkinson-disease

Timeline
28mo left

Started Oct 2024

Longer than P75 for early_phase_1 parkinson-disease

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2024Oct 2028

First Submitted

Initial submission to the registry

September 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

September 1, 2024

Last Update Submit

September 1, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events.

    Safety and tolerability

    Within 24 months post-transplantation

Secondary Outcomes (8)

  • Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.

    Within 24 months post-transplantation

  • Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values.

    Within 24 months post-transplantation

  • Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.

    Within 24 months post-transplantation

  • Assessment of changes in Mini-mental State Examination (MMSE), Hamilton Depression Scale (HAMD)-17 and Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.

    Within 24 months post-transplantation

  • Assessment of changes in Activity of Daily Living Scale (ADL) in comparison with baseline values.

    Within 24 months post-transplantation

  • +3 more secondary outcomes

Study Arms (2)

Low dose

EXPERIMENTAL

MRI-guided bilateral stereotactic cell implantation

Drug: Allogeneic dopaminergic neural precursor cell(iDAP)

High dose

EXPERIMENTAL

MRI-guided bilateral stereotactic cell implantation

Drug: Allogeneic dopaminergic neural precursor cell(iDAP)

Interventions

Allogeneic dopaminergic neural precursor cell(iDAP)DRUG

Bilateral implantation

High doseLow dose

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages between 45 and 75 years;
  • Diagnosed to be Parkinson's disease patients according to MDS Parkinson's disease diagnostic criteria;
  • Disease history 4-20 years;
  • Hoehn and Yahr Stage 2-4;
  • Stable dose of dopamine for more than 3 months;
  • Improvement of MDS-UPDRS part III;

You may not qualify if:

  • Patients who have previously undergone brain surgery;
  • Past use of stem cell therapy or participation in stem cell clinical research;
  • Cognitive impairment;
  • History of mental disorders;
  • Patients with other serious systemic diseases;
  • Past or current metastatic malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Jiong Shi, M.D

CONTACT

6228 3114Jshi2022@ustc.edu.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2024

First Posted

September 4, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

September 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share