---
title: Brain injection reduces movement problems
nct_id: NCT07195825
phase: PHASE1
status: RECRUITING
sponsor: Shanghai Xinzhi BioMed Co., Ltd.
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07195825"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07195825"
last_fetched: "2026-05-10T14:02:14.216Z"
source: "Parkinson's Pathways (curated)"
---
# Brain injection reduces movement problems

**Goal (in five words):** Brain injection reduces movement problems

**Official 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

**Trial ID:** [NCT07195825](https://clinicaltrials.gov/study/NCT07195825)

## Key Facts

- **Phase:** PHASE1
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Shanghai Xinzhi BioMed Co., Ltd.
- **Target Enrollment:** 18 participants
- **Start Date:** 2025-12-27
- **Completion Date:** 2027-12-30
- **Conditions:** PD
- **Interventions:** Injecting BBM-P002 into the bilateral putamen
- **Intervention Types:** GENETIC

## Summary For Families

The goal is to test the safety and tolerability of a one-time, stereotactic bilateral putamen injection of BBM-P002 in people with idiopathic Parkinson's, by delivering the therapy directly into the brain region that controls movement to potentially reduce motor problems. BBM-P002 is given as a single targeted dose into both putamina so it acts locally on the tissues that manage motor function, and participants remain on a stable dose of levodopa or other dopamine-releasing meds so investigators can see how the brain injection behaves alongside standard treatment. This Phase 1, open-label trial plans about 18 participants, ages 40 to 70, who have had Parkinson's for at least five years and show a positive levodopa response. People with major cognitive impairment, contraindications to brain surgery or prior brain surgery, serious medical or lab abnormalities, recent gene or stem-cell or other investigational treatments, pregnancy, or active infections are excluded.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 70 Years
- **Sex:** ALL

### Full Criteria

```
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
```

## Locations (1)

- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China _(31.2222, 121.4581)_
  - Jun Liu, MD — (CONTACT) — 15221303819 — jly0520@hotmail.com
  - Jing Sun, MD — (CONTACT) — 13816899762 — sunjing2@medmail.com.cn
  - Jun Liu, MD — (PRINCIPAL_INVESTIGATOR)
  - Jing Sun, MD — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Wenshu Luo, Ph.D — (CONTACT) — 021-33588288 — luowenshu@beliefbiomed.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07195825*  
*HTML version: https://parkinsonspathways.com/trial/NCT07195825*  
*Source data: https://clinicaltrials.gov/study/NCT07195825*