Evaluation of safety and effectiveness of recurrent umbilical cord-derived stem cell transplantation in patients with ALS

Phase 1

Recruiting

• Conditions: Amyotrophic lateral sclerosis (ALS).; Amyotrophic lateral sclerosis; G12.21

• Registration Number: IRCT20080728001031N32
• Lead Sponsor: Celltech Pharmed Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Age: 18-70
Both gender
Disease onset at least: 6 months
All patients diagnosed with ALS and R/O of differential diagnosis
FVC =40%
ALSFRS-R= 25
Under treatment with rilozule and edaravone
Ability to walk even with aid and ability to tolerate the procedures

Exclusion Criteria

Concomitant psychiatric or cognitive disease
Concomitant systemic disease (uncontrolled HTN, uncontrolled DM, uncontrolled kidney diseases, HF, …)
Treatment with corticosteroid , IVIg, immunosuppressive and cytotoxic during 12 months
Dependency to ventilation
History of malignancy
Concomitant other neurodegenerative disorders

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety. Timepoint: Evaluation of possible side effects at intervals of 24 hours, 1 month, 3 months, 6 and 12 months after injection. Method of measurement: side effects questionnaire.

Secondary Outcome Measures

Name	Time	Method
Changes in ALSFRS-R score. Timepoint: 1, 3, 6 and 12 months after transplantation. Method of measurement: ALSFRS-R questionnaire.;Changes in FVC percent (spirometery). Timepoint: 6 and 12 months after transplantation. Method of measurement: Spirometry.;One-year survival. Timepoint: one year. Method of measurement: visiting the patients.