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NCT Number: NCT06583291

iDAP Injection in the Treatment of Parkinson's Disease

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

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Key information

About this study

Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

Allogeneic dopaminergic neural precursor cell(iDAP)

Drug

Bilateral implantation

Primary outcomes

  1. Incidence and severity of adverse events.

    Time frame: Within 24 months post-transplantation

    Safety and tolerability

Secondary outcomes

  1. 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.

    Time frame: Within 24 months post-transplantation

    Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.

  2. 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.

    Time frame: Within 24 months post-transplantation

    Higher scores mean a worse outcome.

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

    Time frame: Within 24 months post-transplantation

    Comprehensive clinical assessment for examining the improvements in Parkinson disease.

  4. 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.

    Time frame: Within 24 months post-transplantation

    Comprehensive clinical assessment for examining the improvements in mental state.

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

    Time frame: Within 24 months post-transplantation

    Comprehensive clinical assessment for examining the improvements in activity of daily living.

  6. Brain network connectivity patterns as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.

    Time frame: Within 24 months post-transplantation

    Evidence of cell survival

  7. Brain DAT intake index as demonstrated on PET dopamine transporter(DAT) compared with baseline in the 'off' state.

    Time frame: Within 24 months post-transplantation

    Evidence of cell survival

  8. Patient L-dopa equivalent dose compared with baseline.

    Time frame: Within 24 months post-transplantation

    Measure of dopaminergic drug dose.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiong Shi, M.D

CONTACT

[email protected]

6228 3114

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

A Single Center, Open-label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Allogeneic Dopaminergic Neural Precursor Cell(iDAP) Injection in the Treatment of Parkinson's Disease

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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