Peking University Third Hospital Genes Freezing Disease Gene Therapy Drug SNUG01 Patient Recruitment

Recently, Shenji Changhua's amyotrophic lateral sclerosis (also known as ALS)AAV gene therapy drug SNUG01 launched a researcher-initiated clinical study (IIT) in Peking University Third Hospital (hereinafter referred to as "Beijing Third Hospital"), and is currently recruiting patients.

details can be found in previous articles:

Shenji Changhua AAV Gene Therapy Drug SNUG01 Completed the First Subject Administration in the Third Hospital of Beijing Medical University

Shenji Changhua SNUG01 Clinical Study Officially Launched in the Third Hospital of Beijing Medical University

patient recruitment

dear patient friend:

is conducting "a single-arm, open exploratory clinical study to evaluate the single intrathecal injection of SNUG01 in patients with amyotrophic lateral sclerosis", which has been approved by the medical ethics committee of the hospital.

Based on the principle of voluntary participation, we are recruiting patients with amyotrophic lateral sclerosis (ALS) to participate in this study. If you wish and meet the following conditions, you can contact our department.

basic selection conditions:

1.18~65 years old (including 18 years old and 65 years old), men and women are not limited;

2. Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (diagnosed as clinically possible and supporting examination supports ALS or probable ALS or clinically confirmed ALS);

3. The course of ALS must be less than 24 months (counting from the first occurrence of any symptom of ALS to the date of signing the consent form);

4. Body mass index (BMI)≥ 19 kg/m2subjects;

5. Pre-screening ALSFRS-R Pre-study Slope & Delta;FS, measured as & Delta;FS =(48-ALSFRS-R at screening visit) \Duration (months) from onset to screening visit ≥ 0.5 min/month, ALSFRS-R total score ≥ 26 min;

6. Not currently receiving riluzole or have received a stable dose of riluzole for at least 4 weeks prior to Screening Visit. Subjects receiving riluzole are expected to maintain the same dose throughout the study;

7. Not currently receiving Edaravone or receiving approved standard regimen of Edaravone. Subjects who are being treated with edaravone must have completed at least one cycle of treatment prior to the screening visit and expect to continue treatment with edaravone throughout the study;

8. No previous tracheotomy and use of noninvasive ventilation for less than 16 hours per day prior to screening;

9. Negative for human immunodeficiency virus (HIV), syphilis, hepatitis B (negative for hepatitis B surface antigen HBsAg and anti-hepatitis B core antibody anti-HBcAb) or hepatitis C;

10. Has not had any previous gene therapy, hematopoietic stem cell transplantation or solid organ transplantation;

11. Able to understand and voluntarily sign the informed consent form.

If you meet the above main criteria and are willing to participate in this study, please contact the research assistant. You will be further examined by the study doctor to assess compliance with all inclusion and exclusion criteria of the study protocol.

places are limited on a first-come-first-served basis.

Research Assistant: Teacher Ji

contact number: 15710013912 (WeChat has the same number, please add WeChat friends directly for relevant inquiries)

working hours: Monday to Friday 9:00-18:00

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