iDAP Injection in the Treatment of Parkinson's Disease

Early Phase 1

Not yet recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: Allogeneic dopaminergic neural precursor cell(iDAP)

• Registration Number: NCT06583291
• Lead Sponsor: Anhui Provincial Hospital

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-01
• Study First Submitted QC: 2024-09-01
• Last Update Submitted: 2024-09-01
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Study Start: 2024-10-01
• Primary Completion: 2028-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High dose	Allogeneic dopaminergic neural precursor cell(iDAP)	MRI-guided bilateral stereotactic cell implantation
Low dose	Allogeneic dopaminergic neural precursor cell(iDAP)	MRI-guided bilateral stereotactic cell implantation

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events.	Within 24 months post-transplantation	Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
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	Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.
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	Higher scores mean a worse outcome.
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.	Within 24 months post-transplantation	Comprehensive clinical assessment for examining the improvements in Parkinson disease.
Brain network connectivity patterns as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.	Within 24 months post-transplantation	Evidence of cell survival
Brain DAT intake index as demonstrated on PET dopamine transporter(DAT) compared with baseline in the 'off' state.	Within 24 months post-transplantation	Evidence of cell survival
Patient L-dopa equivalent dose compared with baseline.	Within 24 months post-transplantation	Measure of dopaminergic drug dose.
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	Comprehensive clinical assessment for examining the improvements in mental state.
Assessment of changes in Activity of Daily Living Scale (ADL) in comparison with baseline values.	Within 24 months post-transplantation	Comprehensive clinical assessment for examining the improvements in activity of daily living.