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Biomarkers evaluation following MSC therapy in ALS patients

Evaluation of neuro-inflammatory markers for amyotrophic lateral sclerosis (ALS) patients before and after Mesenchymal Stem Cell (MSC) transplantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160809029275N5
Enrollment
25
Registered
2024-05-02
Start date
2022-12-22
Completion date
Unknown
Last updated
2024-05-27

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

Eligible patients will receive one million autologous BM mesenchymal stem cells /Kg BW as intravenous and intrathecal injections by a specialist doctor. The number of injected cells will be equal in b

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor
Parnia knowledge base company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with ALS confirmed by a neurologist with an ALSFRS-R score between 31-46. Patients must have been treated with a stable dose of Rilozule for the previous 3 months. Patients should not have any other chronic diseases and should not use ventilators. Patients in the age range of 18 to 75 years.

Exclusion criteria

Exclusion criteria: Patients with malignancy. Patients with other chronic diseases. pregnancy. Suffering from other neurodegenerative diseases. Simultaneous participation in other clinical trials

Design outcomes

Primary

MeasureTime frame
Earned score based on ALS-FRS test. Timepoint: Before, 1 and 2 months after injection of mesenchymal stem cells. Method of measurement: Standard Questionnaire.;FVC measurement. Timepoint: Before, 1 and 2 months after injection of mesenchymal stem cells. Method of measurement: Using Spirometery test.;Evaluation of serum levels of cytokines, TNFa , MCP-1, NFL, GDNF. Timepoint: Before, 1 and 2 months after injection of mesenchymal stem cells. Method of measurement: Using Elisa method.;Evaluation of MIR 206 , Mir338p, Mir133p expression. Timepoint: Before, 1 and 2 months after injection of mesenchymal stem cells. Method of measurement: Using the Real Time PCR method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Seyed Jalil Tavakol Afshari

Mashhad University of Medical Sciences

Tavakolaj@mums.ac.ir+98 51 3844 0482

Outcome results

None listed

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