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Early safety testing of BBM-P002

Researchers study whether an injection-based experimental treatment can be given safely and tolerated by people with Parkinson’s.

Testing a treatment or activity · Study reference: NCT07195825

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

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Start (reported actual date)
2025-12-27
Main measurements finished (planned)
2027-12-30
Study finished (planned)
2031-12-30

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 40 years to 70 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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
Full study name & original research details

Official study title

A Single-arm, Open-label, Single-dose Clinical Study to Evaluate the Safety and Tolerability of BBM-P002 for Stereotactic Bilateral Putamen Injection in the Treatment of Idiopathic Parkinson's Disease

Short title used by the registry

A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease

Original description

The purpose of the study is to evaluate the safety and tolerability of BBM-P002 for stereotactic injection to treat participants with idiopathic Parkinson's Disease (PD) during the dose-limiting toxicity (DLT) observation period.

Further description from the registry

This is a single-arm, open-label study to evaluate the safety, tolerability, efficacy, pharmacokinetic, pharmacodynamic, and immune response of BBM-P002 within 52 weeks after into the bilateral putamen in Parkinson's disease, as well as the long-term safety and efficacy of BBM-P002 for up to 5 years post injection. BBM-P002 is an AAV-based gene therapy that delivers a therapeutic gene cassette into putamen for the treatment of Parkinson's Disease.

Conditions reported: PD

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Injecting BBM-P002 into the bilateral putamen
Phases
PHASE1
Sponsor
Shanghai Xinzhi BioMed Co., Ltd.
Start date reported by registry
2025-12-27 (actual)

Registry updated: 2026-08-04 · Status last verified by the registry submitter: 2026-08

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Wenshu Luo, Ph.D · 021-33588288 · luowenshu@beliefbiomed.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Recruiting

Jun Liu, MD · 021-64370045 · jly0520@hotmail.com

Jing Sun, MD · 021-34186000 · sunjing2@medmail.com.cn

Jun Liu, MD

Jing Sun, MD

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.