Brain injection trial hopes to tame Parkinson's
NCT ID NCT07195825
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times
Summary
This early-stage study tests whether a new gene therapy called BBM-P002 is safe when injected directly into a specific brain area. It involves 18 adults who have had Parkinson's disease for at least 5 years. The main goal is to check for side effects and see how well the treatment is tolerated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants with a diagnosis of Parkinson's disease for ≥ 5 years. 2. The Hoehn-Yahr staging meets the requirements during the OFF periods. 3. The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive 4. During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly 5. The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase 6. The participants agreed not to participate in any other therapeutic intervention studies during the trial period 7. The participants agreed not to receive the vaccine during the main study phase 8. From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method 9. The participants had good compliance and were able to undergo regular follow-ups. During the follow-up period, they were able to accurately complete the diary cards. Family members, guardians or caregivers could assist the subjects in filling out the diary cards 10. Voluntarilyvoluntarily participated in the study and signed the informed consent form Exclusion Criteria: 1. Atypical or secondary Parkinsonism 2. Have contraindications for surgery or have previously undergone brain surgery 3. The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease 4. Those with severe cognitive impairments 5. Those with severe depression or severe anxiety 6. Abnormal liver function 7. Abnormal coagulation function 8. Abnormalities in infectious disease screening 9. Currently undergoing antiviral treatment for hepatitis 10. Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems 11. Suffering from malignant tumors or having a history of tumors 12. Previous history of severe allergies 13. Exclude those who have participated in other clinical trials within the past three months 14. Had received gene therapy during the screening period 15. Select those who have received stem cell treatment within the past 12 months 16. Exclude those who have used other investigational drugs within the past 4 weeks 17. During the screening period, if the individual had received live vaccines within the previous 2 months, or had a history of vaccination within the last 30 days, they would be excluded. 18. Having a history of alcohol dependence or drug addiction 19. Pregnant or lactating female participants 20. The situations that were determined by the investigator to be unsuitable for inclusion in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200025, China