Stem cell therapy in ALS

Safety and immuno-modulation evaluation of treatment with intravenous and spinal cord injections of of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis (ALS).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160809029275N2

Enrollment

Registered

2020-06-18

Start date

2020-06-21

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

Amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis

Interventions

Intervention group: Group of receiving of Bone marroe-derived mesenchymal stem cells.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with ALS approved by neurologist with 31-46 ALSFRS-R score Patients should be treated with a fixed dose of Rilozule 3 months ago. Patients should not be detrimental to any other chronic disease and do not use ventilator.

Exclusion criteria

Exclusion criteria: Patients with malignancy Patients with other chronic disruptive diseases Pregnancy Others Neurodegenerative disease

Design outcomes

Primary

Measure	Time frame
FVC measurement. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Spirometery test.;Evaluation of TCD4 + CD25 + lymphocyte cells. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Flowcytometery technique.;Earned score based on ALS-FRS test. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Standard Questionnaire.;Evaluation of serum levels of cytokines, IL-1 ß, TNF-a, IL-10, IFN-?. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Elisa method.	—

Measure

Time frame

FVC measurement. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Spirometery test.;Evaluation of TCD4 + CD25 + lymphocyte cells. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Flowcytometery technique.;Earned score based on ALS-FRS test. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Standard Questionnaire.;Evaluation of serum levels of cytokines, IL-1 ß, TNF-a, IL-10, IFN-?. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Elisa method.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Seysd Jalil Tavakol Afshari

Mashhad University of Medical Sciences

Tavakolaj@mums.ac.ir+98 51 3711 2610

Outcome results

None listed

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