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Research Center: Peking University Third Hospital

Location: This is a single center clinical trail conducted in Beijing, China.

Lead Researcher: Dongshen Fan, Ph.D.

IRB: This study has been reviewed and approved by the Peking University Third Hospital Institutional Review Board

About the study

Amyotrophic lateral sclerosis (ALS) is a rare neurodegenerative disease that affects nerve cells in the brain and spinal cord. ALS causes loss of muscle control, affecting the muscles needed to move, speak, eat and breathe. Decline is inevitable, with death from respiratory failure following 2 to 5 years after diagnosis for most people.

Researchers are seeking ways to help people with ALS. This study will investigate whether a single intrathecal injection of SNUG01 can help prevent the progression of the disease.

This study is inviting ALS patients aged 18 to 65 years old. Participants must be willing to comply with the study requirements.

Who Can Participate?

1. Participants who are able to submit written informed consent.

2. Participants must be 18 to 65 years of age inclusive.

3. Participants must have been diagnosed with clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised El Escorial World Federation of Neurology criteria.

4. Participants within 2-year elapsed time period from first symptom onset at the screening visit.;

5. Participants with a body mass index (BMI) ≥19 kg/m2.

6. Participants with ALSFRS-R progression rate (ΔFS) , measured asΔFS= (48-ALSFRS-R score at the screening visit）/duration in months between the screening visit and disease onset, ≥ 0.5 points/ month and ALSFRS-R total score≥26 at the screening visit.

7. Participants must either not currently receiving riluzole or on a stable dose of riluzole for at least 4 weeks prior to the screening visit. Participants receiving riluzole are expected to remain the same dose throughout the study.

8. Participants is not currently on edaravone treatment or is receiving an approved standard edaravone regimen. Participants receiving edaravone must have completed at least 1 cycle of treatment prior to the screening visit and are expected to continue with edaravone throughout the study period.

9. Participants must not require tracheotomy or use non-invasive ventilation less than 16 hours per day prior to screening.

10. Participants must not be exposure to gene therapy, stem cell products and solid organ transplantation.

Sign Me UP

If you meet the above criteria and would like to take part in this study, please contact us below for full details.

Email: neurbj@126.com