- |||||||||| AB-1005 / Bayer
Trial completion date, Trial primary completion date, Gene therapy: GDNF Gene Therapy for Multiple System Atrophy (clinicaltrials.gov) - Oct 16, 2023
P1, N=9, Recruiting,
A phase 2 randomized controlled study is planned to confirm these findings. Trial completion date: Mar 2026 --> Dec 2028 | Trial primary completion date: Mar 2024 --> Dec 2025
- |||||||||| AB-1005 / Bayer
Enrollment closed, Gene therapy: GDNF Gene Therapy for Parkinson's Disease (clinicaltrials.gov) - Jan 5, 2023
P1, N=11, Active, not recruiting,
Similarly, the novel concept of robotic actuators that are powered, imaged, and controlled by the MRI itself is discussed in this article, with its potential for seamless cranial neurosurgery. Recruiting --> Active, not recruiting
- |||||||||| AB-1005 / Bayer
Enrollment open, Trial completion date, Trial primary completion date, Gene therapy: GDNF Gene Therapy for Multiple System Atrophy (clinicaltrials.gov) - Jul 26, 2022
P1, N=9, Recruiting,
This delivery-imaging platform enhances safety, permits delivery personalization, improves therapeutic distribution, and facilitates the assessment of efficacy and dosing effect. Not yet recruiting --> Recruiting | Trial completion date: Nov 2025 --> Mar 2026 | Trial primary completion date: Apr 2023 --> Mar 2024
- |||||||||| AAV2-GDNF / Bayer
Safety and Preliminary Clinical Findings of Neurosurgical AAV2-GDNF Delivery for Parkinson’s Disease (Poster Board Number: Tu-301; Hall D) - May 8, 2022 - Abstract #ASGCT2022ASGCT_1976;
Asymptomatic, procedure-related radiographic findings were identified at 6 months without clinical sequelae.Although interpretation of clinical outcomes in small open-label studies is limited by the placebo effect, we believe these results showing stability of UPDRS III OFF/ON scores in the Early Cohort, and improvements in the Moderate Cohort are encouraging. Ongoing clinical follow-up and planned controlled studies are needed to confirm these early clinical observations.
- |||||||||| AAV2-GDNF / Bayer
Long-Term Safety of Intraparenchymal Administration of AAV2-GDNF and Gadolinium in Parkinson's Disease (Poster Board Number: Tu-292; Hall D) - Apr 20, 2022 - Abstract #ASGCT2022ASGCT_883;
MR-imaging did not detect signs of a localized inflammatory response to the therapeutic co-infusions, up to 5 years following CED (Figure 1). Cannula track volumes were consistently present but significantly reduced by 36-, 48- and 60-month MR assessments.Co-infusion of gadolinium with AAV2-GDNF was safe and well-tolerated in 13 advanced PD participants, up to 5 years post-treatment, without evidence of parenchymal toxicity.
- |||||||||| AB-1005 / Bayer
Trial completion date, Trial primary completion date, Gene therapy: GDNF Gene Therapy for Multiple System Atrophy (clinicaltrials.gov) - Mar 8, 2022
P1, N=9, Not yet recruiting,
Cannula track volumes were consistently present but significantly reduced by 36-, 48- and 60-month MR assessments.Co-infusion of gadolinium with AAV2-GDNF was safe and well-tolerated in 13 advanced PD participants, up to 5 years post-treatment, without evidence of parenchymal toxicity. Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2022 --> Apr 2023
- |||||||||| AB-1005 / Bayer
Trial completion date, Trial primary completion date, Gene therapy: GDNF Gene Therapy for Parkinson's Disease (clinicaltrials.gov) - Feb 24, 2022
P1, N=12, Recruiting,
Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2022 --> Apr 2023 Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| AB-1005 / Bayer
Trial completion, Metastases: AAV2-GDNF for Advanced Parkinson s Disease (clinicaltrials.gov) - Feb 8, 2022
P1, N=25, Completed,
Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Dec 2022 --> Dec 2023 Active, not recruiting --> Completed
- |||||||||| AB-1005 / Bayer
Trial completion date, Trial initiation date, Trial primary completion date, Gene therapy: GDNF Gene Therapy for Multiple System Atrophy (clinicaltrials.gov) - Jul 22, 2021
P1, N=9, Not yet recruiting,
Furthermore, an intracerebral dose of 6.8 × 10 AAV2-GDNF vg/dose was considered to be a no observed adverse effect level in rats. Trial completion date: Apr 2024 --> Nov 2024 | Initiation date: Apr 2021 --> Nov 2021 | Trial primary completion date: Apr 2022 --> Nov 2022
- |||||||||| AB-1005 / Bayer
Trial completion date, Trial initiation date, Trial primary completion date, Gene therapy: GDNF Gene Therapy for Multiple System Atrophy (clinicaltrials.gov) - Apr 22, 2021
P1, N=9, Not yet recruiting,
Trial completion date: Apr 2024 --> Nov 2024 | Initiation date: Apr 2021 --> Nov 2021 | Trial primary completion date: Apr 2022 --> Nov 2022 Trial completion date: Jan 2024 --> Apr 2024 | Initiation date: Jan 2021 --> Apr 2021 | Trial primary completion date: Jan 2022 --> Apr 2022
- |||||||||| AB-1005 / Bayer
Enrollment open, Gene therapy: GDNF Gene Therapy for Parkinson's Disease (clinicaltrials.gov) - Dec 19, 2019
P1, N=12, Recruiting,
Trial completion date: Jan 2024 --> Apr 2024 | Initiation date: Jan 2021 --> Apr 2021 | Trial primary completion date: Jan 2022 --> Apr 2022 Not yet recruiting --> Recruiting
- |||||||||| AAV2-GDNF / uniQure, University of California, National Institute of Neurological Disorders and Stroke
Bilateral Putaminal AAV2-GDNF Delivery the Treatment of Advanced Parkinson’s Disease (Les Muses Terrace, Level 3) - Sep 24, 2019 - Abstract #MDSCongress2019MDS_215;
Not yet recruiting --> Recruiting The safety of this GDNF gene therapy in advanced PD patients, as shown by the preliminary results obtained in this Phase I trial to date, supports a new human trial in early and advanced PD patients that extends similar and higher vector doses and maximizes putaminal coverage by increasing infusion volume and utilizing a novel surgical trajectory.
- |||||||||| AB-1005 / Bayer
Trial completion date, Metastases: AAV2-GDNF for Advanced Parkinson s Disease (clinicaltrials.gov) - Sep 23, 2019
P1, N=25, Active, not recruiting,
The safety of this GDNF gene therapy in advanced PD patients, as shown by the preliminary results obtained in this Phase I trial to date, supports a new human trial in early and advanced PD patients that extends similar and higher vector doses and maximizes putaminal coverage by increasing infusion volume and utilizing a novel surgical trajectory. Trial completion date: Dec 2027 --> Feb 2022
- |||||||||| AB-1005 / Bayer
Trial primary completion date, Metastases: AAV2-GDNF for Advanced Parkinson s Disease (clinicaltrials.gov) - Apr 20, 2019
P1, N=25, Active, not recruiting,
Trial completion date: Dec 2027 --> Feb 2022 Trial primary completion date: Jan 2025 --> Jan 2022
- |||||||||| AB-1005 / Bayer
Enrollment closed, Enrollment change, Metastases: AAV2-GDNF for Advanced Parkinson s Disease (clinicaltrials.gov) - Feb 5, 2018
P1, N=25, Active, not recruiting,
Trial primary completion date: Jan 2025 --> Jan 2022 Recruiting --> Active, not recruiting | N=100 --> 25
- |||||||||| AB-1005 / Bayer
Trial primary completion date, Metastases: AAV2-GDNF for Advanced Parkinson s Disease (clinicaltrials.gov) - Dec 15, 2016
P1, N=100, Recruiting,
Recruiting --> Active, not recruiting | N=100 --> 25 Trial primary completion date: Jan 2018 --> Jan 2025
- |||||||||| AB-1005 / Bayer
Enrollment change, Metastases: AAV2-GDNF for Advanced Parkinson s Disease (clinicaltrials.gov) - Apr 8, 2013
P1, N=100, Recruiting,
Trial primary completion date: Jan 2018 --> Jan 2025 N=28 --> 100
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