Amyotrophic lateral sclerosis
Conditions
Interventions
Case series:T cell therapy + Herb Qu + Interleukin-2
Sponsors
Nanjing Hospital Affiliated to Nanjing University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. This study referred to the confirmed and probably ALS patients in the revised EI escorial2012 ALS diagnostic criteria; 2. The patients and their family members agreed that they could understand the purpose of the trial, voluntarily accepted the clinical trial and signed the written informed consent, and accepted the neuromuscular experts of the Department of Neurology of the second hospital of Nanjing for evaluation and clinical follow-up; 3. Subjects who were allowed to use or did not use riluzole in this study. 4. Onset age > 18 years old; 5. During the study period and three months after the completion of the study, women should not become pregnant. 6. Subjects must agree not to take live attenuated vaccine (including seasonal influenza vaccine) 30 days before blood collection; 7. Flow cytometry was used to determine the autogenous Tregs products with more than or equal to 50% expression of CD4, CD25 and Foxp3; 8. Normal alanine aminotransferase (ALT) and normal serum creatinine levels; 9. FVC predicted 40% or more at screening.
Exclusion criteria
Exclusion criteria: 1. Other possible diagnoses include SMA, Kennedy's disease, peripheral neuropathy, ALS syndrome, and immune system diseases; 2. Cell therapy was used before; 3. Other e13. Chinese medicine preparations are being used for treatment. 4. Pregnancy or lactation or planned pregnancy or planned partner pregnancy; 5. Other unstable physical or mental diseases; 6. Past history of immunodeficiency or lymphoma or leukemia; 7. The history of lymphopenia; 8. History of acquired or inherited immunodeficiency syndrome, including leukopenia; 9. History of severe untreated chronic obstructive sleep apnea. 10. Within 30 days of baseline follow-up, contact with any other drug currently under investigation for the treatment of ALS (off label use or study) subjects; 11. According to PI judgment, or the history of active substance abuse in the past year, the presence of unstable mental illness, cognitive impairment or dementia may impair the ability of subjects to provide informed consent; 12. History of other serious systemic diseases, such as significant heart, tumor, respiratory system, liver or renal insufficiency or other medical major diseases; 13. Patients with life expectancy less than 3 months or unable to complete the study due to other reasons; 14. Those who have a history of drug allergy or food allergy and are known to be allergic to the drug ingredients in this study; 15. Patients considered unsuitable for the study by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALSFRS-R;Pulmonary function;T-Regulatory Cells;Treg Suppression;NK cells;Appel ALS Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| routine blood test;Blood biochemistry;blood coagulation; | — |
Countries
China
Contacts
Public ContactJin Qingwen
Nanjing Medical University
Outcome results
None listed