|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 February 2025 |
|
Main ID: |
NCT06821529 |
|
Date of registration:
|
04/02/2025 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Stereotactic Intracerebral Injection of IPSC-DAPs in Patients with Parkinson's Disease
|
|
Scientific title:
|
Stereotactic Intracerebral Injection of Autologous Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients with Parkinson's Disease |
|
Date of first enrolment:
|
May 15, 2025 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT06821529 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Baorong Zhang |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
|
|
Name:
|
Gao Chen |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
|
|
Name:
|
Jiali Pu, PhD |
|
Address:
|
|
|
Telephone:
|
+86 13989468062 |
|
Email:
|
jialipu@zju.edu.cn |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Able to sign informed consent and comply with the study protocol
- 39-75 years of age, at the time of signing informed consent
- Diagnosed to be Parkinson's disease patients over 5 years
- Taking levodopa, but with complications of therapy such as wearing off and/or
dyskinesia
- At least 3 hours accumulative "off" time per day
- Hoehn and Yahr Stage 2.5 - 4 in the off state at screening
- Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least
a 30% improvement on UPDRS III (motor) scale
Exclusion Criteria:
- Patients with the following concomitant conditions or disorders: Epilepsy;Multiple
sclerosis;Unable to give consent due to dementia;Atypical Parkinsonism;Genetic
Parkinson's disease;Suicidal ideation associated with intent or plan in the past 12
months;History of psychosis;History of subarachnoid hemorrhage;History of stroke or
transient ischemic attack
- Patient with unstable vital sign at screening and/or prior to the surgery:
- Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2
- Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times
the ULN.
- Hematologic abnormality: hemoglobin <10 mg/dL or platelet count < 100,000/mL
- International normalized ratio (INR) = 1.3 not due to a reversible cause
- Patients with autoimmune disorders
- Patients with HIV and/or active HBV or HCV
- Patients who are unable to undergo MRI and PET/CT
- Patients with an expected life expectancy of <1 year
- Patients who have had active malignancies
- Patients currently receive levodopa-carbidopa intestinal gel or apomorphine
treatment
- Patients who have history of pallidotomy or thalamotomy or deep brain stimulation
(DBS) surgery
- Received cell or gene therapy (autologous or allogeneic) within the previous 12
months
- Participation in an investigational therapeutic or device trial within 30 days of
consent
- Women who are pregnant or breast-feeding
- Other conditions that researchers consider not suitable to participate in this study
Age minimum:
39 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson Disease
|
|
Intervention(s)
|
|
Biological: ICA07 therapy
|
|
Primary Outcome(s)
|
|
Incidence and servility of Treatment-Emergent Adverse Events
[Time Frame: From baseline to 12 months post surgery]
|
|
Secondary Outcome(s)
|
|
changes in motor function
[Time Frame: From baseline to 12 months post surgery]
|
|
Changes in the Hoehn and Yahr scale
[Time Frame: From baseline to 12 months post surgery]
|
|
Change in PD medication usage
[Time Frame: From baseline to 12 months post surgery]
|
|
18-F DAT PET uptake
[Time Frame: Baseline, 6 and 12 months post surgery]
|
|
Changes in quality of life (QoL)
[Time Frame: From baseline to 12 months post surgery]
|
|
Secondary ID(s)
|
|
(2025)LSYD(0172)H
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|