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Completed · registry status

Safety and Efficacy Study of Parkinson's Disease Gene Therapy Drug (BBM-P002)

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Testing a treatment or activity · Study reference: NCT05822739

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This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Follow this study

Completed; watching for results

Start (reported actual date)
2023-04-14
Main measurements finished (reported actual date)
2025-10-30
Study finished (reported actual date)
2025-10-30

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 — completed

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

Papers connected to this study

Dual-target gene therapy in Parkinson's disease: a multicenter phase 1 trial.
Listed by the registry as research derived from the study · 2026

Participation rules recorded for this study

Ages 40 years to 65 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. Clinically confirmed diagnosis of idiopathic Parkinson's Disease (PD) in accordance with the 2015 Movement Disorder Society (MDS) diagnostic criteria. 2. Participants aged between 40 and 65 years, inclusive, of any gender. 3. A disease history of five years or more. 4. A Hoehn and Yahr (H-Y) stage of 2.5 to 4 in the Of-state. 5. An adeno-associated virus (AAV) neutralizing antibody titer of fit thecriteria. 6. A Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score greater than 35 in the Off-state, with an improvement of at least 30% following an acute levodopa challenge test. 7. Stable anti-Parkinsonian medication regimen prior to the screening period for at least four weeks. 8. The subject must agree to postpone any other neurosurgical procedures (including deep brain stimulation) during the main study phase, with the exception of emergency neurosurgery for life-threatening conditions. 9. The subject must agree not to participate in other therapeutic interventional studies during the main study phase. 10. The subject must agree not to undergo vaccination during the main study phase. 11. Commitment to using a reliable method of contraception from the screening period until at least 52 weeks post-infusion. 12. The subject must be compliant and capable of attending regular follow-up appointments. The subject must be able to accurately complete a PD patient diary during the follow-up period, with assistance from family members, guardians, or caregivers permitted. 13. The subject must be fully informed about the nature, objectives, procedures, and potential adverse effects of the clinical trial, and must voluntarily consent to participate by signing the informed consent form. In cases where the subject is unable to read, a legally authorized representative or an impartial witness may read the informed consent form and other written materials to them and witness the consent process. Exclusion Criteria: 1. Diagnosis of atypical or secondary parkinsonian syndromes (e.g., Parkinson-plus syndromes, hereditary parkinsonian syndromes, drug-induced parkinsonism). 2. Presence of surgical contraindications, a history of prior brain surgery such as deep brain stimulation (DBS), pallidotomy, or extrapyramidal surgery, or any other neurosurgical procedure that the investigator deems would interfere with participation in this trial. 3. Previous cranial imaging showing structural brain abnormalities, cerebrovascular malformations, intracranial tumors, risk of intracranial hemorrhage, traumatic brain injury, or other significant anomalies. 4. A Mini-Mental State Examination (MMSE) score of \<24. 5. A Patient Health Questionnaire-9 (PHQ-9) score of ≥16. 6. Abnormal liver or kidney function, defined as: Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>1.5 times the upper limit of normal (ULN), or serum creatinine (Cr) \>1.5 times the ULN. 7. Coagulation dysfunction or current use of anticoagulant agents. 8. Positive screening for infectious diseases: positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B virus DNA (HBV-DNA), positive for Hepatitis C virus RNA (HCV-RNA), positive for Human Immunodeficiency Virus (HIV), or seropositive for syphilis. 9. Currently undergoing antiviral treatment for Hepatitis B or C. 10. Presence of unstable or severe concomitant systemic diseases, including but not limited to active tuberculosis, or diseases of the cardiovascular, respiratory, digestive, urinary, neuropsychiatric (e.g., epilepsy), hematologic, or immune systems, or abnormal laboratory values that, in the judgment of the investigator, would make the subject unsuitable for the trial. 11. Current or prior history of a malignant tumor. 12. History of a severe allergic reaction, allergy to contrast agents, or inability to tolerate surgical anesthesia. 13. Current participation in another clinical trial, or participation in any other clinical trial within 3 months prior to the screening period. 14. Prior history of gene therapy before screening. 15. Receipt of stem cell therapy within 6 months prior to the screening period. 16. Use of other investigational drugs within 4 weeks prior to screening or within 5 half-lives of the drug (whichever is longer), or any medication judged by the investigator to interfere with the trial. 17. Receipt of a live vaccine within 2 months prior to the screening period, or any vaccination within 30 days prior to the screening period. 18. History of alcohol dependence or drug addiction, with an inability to adhere to medical advice to abstain from alcohol during the trial period. 19. Female subjectsparticipants who are pregnant or lactating. 20. Any subject deemed unsuitable for enrollment based on the investigator's assessment.
Full study name & original research details

Official study title

A Single-Arm, Open-Label, Exploratory Clinical Study of BBM-P002 Gene Therapy for Parkinson's Disease

Short title used by the registry

Safety and Efficacy Study of Parkinson's Disease Gene Therapy Drug (BBM-P002)

Original description

Safety and Efficacy Study of BBM-P002 in participants with primary advanced Parkinson's disease

Further description from the registry

Parkinson's disease is a neurodegenerative disorder involving loss of dopaminergic neurons in the substantia nigra. This study is a single-center, single-arm, open-label, treatment clinical study to evaluate the safety, tolerability and efficacy of an adeno-associated virus (AAV)-based gene therapy, termed BBM-P002, will be injected into the brain via a neurosurgical procedure.

Conditions reported: Parkinson's Disease

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
BBM-P002
Phases
EARLY_PHASE1
Sponsor
Xiangya Hospital of Central South University
Start date reported by registry
2023-04-14 (actual)

Registry updated: 2026-01-15 · Status last verified by the registry submitter: 2026-01

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.

No central contact is listed. Check the location contacts or the official registry record.

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.

Xiangya Hospital of Central South University

Changsha, Hunan, China

Status not reported

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Status not reported

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