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Investigating the simultaneous effect of nanocurcumin and autologous mesenchymal stem cells in ALS patients

Investigating the simultaneous effect of intrathecal and intravenous injection of autologous mesenchymal stem cells and nanocurcumin consumption in patients with Amyotrophic Lateral Sclerosis (ALS)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160809029275N4
Enrollment
20
Registered
2024-04-04
Start date
2024-06-21
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

Intervention 1: Intervention group: Receiving autologous mesenchymal stem cells from the bone marrow ( 1 million cell/kg BW), along with common treatments (physiotherapy and occupational therapy) alo

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor
Pernia Knowledge-based Company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Definite Amyotrophic Lateral Sclerosis ( ALS) patients who have been diagnosed with ALS by a specialist neurologist and have The Revised Amyotrophic Lateral Sclerosis Functional Rating Scale-R (ALSFRS-R) of 31 to 46 Patients who have been treated with a define dose of Rilozule for the past three months. Patients who have entered the study by filling the informed consent form. Patients who do not use ventilators Patients who do not have any other chronic diseases that may interfere with the study.

Exclusion criteria

Exclusion criteria: The presence of specific autoimmune and underlying diseases, cancer and any malignancy. Simultaneous participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Determination of The Revised Amyotrophic Lateral Sclerosis Functional Rating Scale ( ALSFRS-R). Timepoint: Before the study and 6 months after the intervention. Method of measurement: Using an international standard questionnaire.;Determination of Forced vital capacity (FVC). Timepoint: Before the study and 6 months after the intervention. Method of measurement: Using a spirometry test.

Secondary

MeasureTime frame
Measurement of IL-10, TGF-? and IL-4 cytokines. Timepoint: Before the study and 6 months after the intervention. Method of measurement: Elisa test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Seysd Jalil Tavakol Afshari

Mashhad University of Medical Sciences

Tavakolaj@mums.ac+98 51 3711 2610

Outcome results

None listed

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