Actively Recruiting

Phase 1
Age: 30Years - 85Years
All Genders
NCT05901818

Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease

Led by Xuanwu Hospital, Beijing · Updated on 2023-06-22

10

Participants Needed

1

Research Sites

185 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase I, interventional, single arm, open-label, clinical study to evaluate the safety and efficacy of the striatal transplantation of autologous induced neural stem cell-derived DA precursor cells in Parkinson's Disease patients.

CONDITIONS

Official Title

Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease

Who Can Participate

Age: 30Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 30 and 85 years, any gender
  • Diagnosed with Parkinson's Disease based on MDS diagnostic criteria
  • Parkinson's Disease duration longer than 3 years
  • Hoehn and Yahr stage 4 or less during medication on-time
  • Responsive to levodopa treatment with over 30% improvement in MDS-UPDRS part 3 score
Not Eligible

You will not qualify if you...

  • Diagnosed with atypical or secondary Parkinsonian syndrome
  • Having other central nervous system diseases
  • Presence of severe systemic diseases or dysfunction
  • Having severe psychiatric disorders
  • Currently using hormone or cytotoxic drugs that cannot be stopped during the trial
  • Cognitive impairment with MMSE score below 24
  • Severe dyskinesia with MDS-UPDRS part 4 scores 4.1/4.2 equal or above 2
  • Previous brain surgery
  • Long-term use of anticoagulants
  • Intracranial lesions affecting surgery or follow-up as shown by imaging
  • Unable to undergo MRI or AV133 PET scans
  • Pregnancy or planning pregnancy
  • Deemed unsuitable for the trial by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

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Research Team

Z

Zhiguo Chen, Ph.D.

CONTACT

J

Jinghong Ma, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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