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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
NCTID
NCT06285643
(View at clinicaltrials.gov)
Description
The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.
(Show More)
Indication
Parkinson Disease
Compound Name
AB-1005 (AAV2-GDNF)
Sponsor
AskBio Inc
Funder Type
Industry
Status
Recruiting
Enrollment Count
87
Therapy Information
Target Gene/Variant
GDNF
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Overexpression of protective allele/gene
Route of Administration
CED
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV2
Editor Type
none
Dose 1
Up to 1.8mL (3.3E12 vg/ml/gadoteridol 2mM co-infusion)
Dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase2
Submit Date
2024-02-14
Completion Date
2027-11-30
Last Update
2025-02-17
Participation Criteria
Eligible Age
45 Years - 75 Years
Standard Ages
Adult, Older adult
Eligible Sex
ALL
Locations
No.of Trial Sites
26
Locations
United States
Regulatory Information
Has US IND
True
Recent Updates
Received FDA Fast Track designation
Resources/Links
Clinical Publications
Long-term safety of MRI-guided administration of AAV2-GDNF and gadoteridol in the putamen of individuals with Parkinson's disease
(Abstract) Phase 1b Safety and Preliminary Efficacy of Bilateral Intraputaminal Delivery of AAV2 GDNF (AB-1005) in Participants With Mild or Moderate Parkinsonâs Disease - AAN Meeting, April 2024
Trial of magnetic resonance-guided putaminal gene therapy for advanced Parkinson's disease
Persistent GDNF Expression 45 Months after Putaminal Infusion of AAV2-GDNF in a Patient with Parkinson's Disease
News and Press Releases
AskBio Welcomes Brain Neurotherapy Bio to Expand Clinical Pipeline for Neurodegenerative Diseases
AskBio presents 18-month Phase Ib trial results of AB-1005 gene therapy for patients with Parkinsonâs disease
AskBio receives FDA Fast Track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinsonâs disease
Preclinical Publications
Clinically relevant effects of convection-enhanced delivery of AAV2-GDNF on the dopaminergic nigrostriatal pathway in aged rhesus monkeys
Intermittent convection-enhanced delivery of GDNF into rhesus monkey putamen: absence of local or cerebellar toxicity
Anterograde axonal transport of AAV2-GDNF in rat basal ganglia
Evaluation of an AAV2-based rapamycin-regulated glial cell line-derived neurotrophic factor (GDNF) expression vector system
Regeneration of the MPTP-lesioned dopaminergic system after convection-enhanced delivery of AAV2-GDNF
Functional effects of AAV2-GDNF on the dopaminergic nigrostriatal pathway in parkinsonian rhesus monkeys
Interventional MRI-guided putaminal delivery of AAV2-GDNF for a planned clinical trial in Parkinson's disease
Safety Assessment of AAV2-hGDNF Administered Via Intracerebral Injection in Rats for Treatment of Parkinson's Disease
Safety evaluation of AAV2-GDNF gene transfer into the dopaminergic nigrostriatal pathway in aged and parkinsonian rhesus monkeys
Protocol
Clinical Trial Protocol