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Efficacy and safety of ECIWEP protein injection in the treatment of amyotrophic lateral sclerosis: a single-arm, open-label, single-center clinical trial

Efficacy and safety of ECIWEP protein injection in the treatment of amyotrophic lateral sclerosis: a single-arm, open-label, single-center clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074923
Enrollment
Unknown
Registered
2023-08-21
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis

Interventions

therapy:ECIWEP THERAPY

Sponsors

Tsinghua University Yuquan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with amyotrophic lateral sclerosis (ALS) after medication; 2. The modified amyotrophic Lateral Sclerosis Function Scale score (ALSFRS-R) was =2 points for each item (including dyspnea and upright breathing) Aspiration and respiratory dysfunction must all be 4 points); 3. The percentage of forced vital capacity to the estimated value (FVC%) =60%; 4. The course of the disease is 2 years or less (from the first appearance of any symptoms of ALS); 5. Age 45-70 years old (including 45 and 70 years old), gender is not limited; 6. Voluntarily participate in this clinical trial, give informed consent and sign informed consent

Exclusion criteria

Exclusion criteria: 1. Those diagnosed with familial ALS (based on family history); 2. Those with obvious cognitive impairment (MMSE scale: illiterate group =19 points, primary school group =22 points, junior high school and above group (greater than 8 years of education) =26 points); 3. Significant dysphagia; 4. Severe renal insufficiency: creatinine clearance 3 times the upper limit of normal value, or other known liver diseases such as acute and chronic activity Hepatitis, cirrhosis, etc.; 6. During the screening period, patients with acute myocardial infarction or interventional therapy within the last 6 months and heart failure (according to the NYHA classification as Grade III-IV patients); 7. Complicated with malignant tumors, serious diseases of blood, digestion or other systems; 8. Allergies; 9. Pregnancy and lactation; 10. Within 30 days prior to screening 11. Other situations deemed unsuitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
Respiratory examination;electromyography;CSF;blood;—

Countries

CHINA

Contacts

Public Contactzhiqiang cui

Tsinghua University Yuquan Hospital

15210097470@163.com+86 88257755

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026