Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease
ConditionParkinson's Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-85
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Autologous induced neural stem cell-derived DA precursor cells
DrugThe autologous induced neural stem cell-derived DA precursor cells will be stereotactically implanted into the striatum of PD patients.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Autologous induced neural stem cell-derived DA precursor cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of changes during the medication "off" time in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.
Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.
Time frame
Within 12 months post-transplantation2
Incidence and severity of transplant-related adverse events.
Time frame
Within 12 months post-transplantationSecondary outcomes
1
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I, in comparison with baseline values.
Minimum score: 0; Maximum score: 52; Higher scores mean a worse outcome.
Time frame
Within 12 months post-transplantation2
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part II, in comparison with baseline values.
Minimum score: 0; Maximum score: 52; Higher scores mean a worse outcome.
Time frame
Within 12 months post-transplantation3
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part IV, in comparison with baseline values.
Minimum score: 0; Maximum score: 24; Higher scores mean a worse outcome.
Time frame
Within 12 months post-transplantation4
Assessment of changes during the medication "off" time in motor function by using Purdue Pegboard test and gait analyzer, in comparison with baseline values.
Time frame
Within 12 months post-transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov