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IRCT20251207068238N1 IRCT 2026-05-29 Bagheiat-allah University of Medical Sciences Safety assessment of intrathecal and intravenous mesenchymal umbilical cord-derived stem cells in multiple sclerosis patients Safety assessment of intrathecal and intravenous mesenchymal umbilical cord-derived stem cells in multiple sclerosis patients 2026-06-05 anticipated 5 Complete https://irct.ir/trial/90386 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Given the phase I design of the present clinical trial and its primary focus on safety assessment, a very small sample size will be employed. Consistent with several previous phase I studies that included sample sizes ranging from 5 to 8 participants, the sample size for the current study was determined to be five participants. Eligible subjects will be selected from the study population according to the predefined inclusion and exclusion criteria using a randomized double-blind design. 1 Multiple Sclerosis. Intervention group: Intervention Group:Patients with Multiple Sclerosis (MS) will receive simultaneous administration of human umbilical cord-derived mesenchymal stem cells (UC-MSCs). The cells will be isolated, expanded, and quality-controlled under Good Manufacturing Practice (GMP) conditions, including sterility, viability, and contamination testing.The intervention consists of:1. Intravenous (IV) administration of UC-MSCs2. Intrathecal (IT) administration of UC-MSCsAll injections will be performed at Baghiatallah Hospital by an experienced neurologist. Following administration, patients will be monitored for immediate and delayed adverse events through clinical assessments, laboratory evaluations, and brain MRI imaging, and will be followed for 12 months.. Yes - There is a plan to make this available What will be shared: Data will be anonymized and published only if required for scientific or research purposes. When: No restrictions To whom: Anonymized data may be shared or published, if required, for relevant authorities, stakeholders, and journal reviewers. Conditions: If needed Where to obtain: The Correspondent How to obtain: By Email request Comments:
public Ramtin Naderian
mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran
Tehran Iran (Islamic Republic of) ۱۴۳۵۹۱۵۳۸۱ +98 21 8804 0060 ramtinndn@gmail.com Bagheiat-allah University of Medical Sciences scientific Ramtin Naderian
mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran
Tehran Iran (Islamic Republic of) ۱۴۳۵۹۱۵۳۸۱ +98 21 8804 0060 ramtinndn@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Definite diagnosis of Multiple Sclerosis according to the 2017 McDonald criteria. Age between 18 and 55 years old. Mild to moderate disability (Expanded Disability Status Scale [EDSS] score between 1 and 6). No acute relapse within the previous 3 months. Provision of written informed consent for participation in the study. 18 years 55 years Both Treatment - Other Intervention group: Intervention Group:Patients with Multiple Sclerosis (MS) will receive simultaneous administration of human umbilical cord-derived mesenchymal stem cells (UC-MSCs). The cells will be isolated, expanded, and quality-controlled under Good Manufacturing Practice (GMP) conditions, including sterility, viability, and contamination testing.The intervention consists of:1. Intravenous (IV) administration of UC-MSCs2. Intrathecal (IT) administration of UC-MSCsAll injections will be performed at Baghiatallah Hospital by an experienced neurologist. Following administration, patients will be monitored for immediate and delayed adverse events through clinical assessments, laboratory evaluations, and brain MRI imaging, and will be followed for 12 months. Incidence and severity of adverse events based on CTCAE criteriaChange in EDSS score from baselineChange in Timed 25-Foot Walk Test performanceChange in the number of brain MRI plaquesChange in serum NFL levelsChange in inflammatory cytokine levels. Timepoint: since the first day to 6 months after that. Method of measurement: The following instruments will be used for data collection in this study:Standardized clinical checklist including:* Vital signs (blood pressure, pulse rate, body temperature, respiratory rate, and SpO₂)* Acute post-injection adverse events (headache, nausea, low back pain, seizure, infection)* EDSS assessment performed by an experienced neurologist specialized in MSStandard paraclinical assessments:* Liver function tests (AST, ALT, ALKP, Bilirubin)* Renal function tests (BUN, Creatinine)* Complete blood count (CBC)* ESR and CRP* Fasting blood glucose* Urinalysis (U/A)* Electrocardiography (EKG)Brain MRI with and without gadolinium contrast enhancement:* Interpreted by an expert neuroradiologistSafety monitoring:* Safety Monitoring Form checklist* Monitoring of immediate adverse events (0–24 hours)* Monitoring of delayed adverse events (1 week, 1 month, and 3 months)Validity of Instruments:Not applicable in this study.Reliability and Validity of Instruments:Content Validity:All instruments and assessments (CBC, LFT, RFT, MRI, EDSS, and EKG) are internationally standardized and approved (FDA-approved / CE-marked) and are routinely used in validated clinical safety protocols; therefore, no additional validation is required.Construct Validity:Measures such as EDSS, MRI findings, and inflammatory biomarkers are among the most established tools for evaluating disease status and treatment safety in MS patients.Reliability:* Inter-rater reliability: EDSS assessments will be performed by the same experienced neurologist to ensure consistency.* Test–retest reliability: Laboratory assessments (CBC, LFT, RFT) and MRI evaluations have established technical reliability and will be performed by the same technicians and radiologist throughout the study.Sample Size and Sample Size Calculation:Given the phase I design of the study and its primary focus on safety evaluation, a small sample size will be used. Consistent with previous similar studies that included 5–8 participants, the sample size of the present study was determined to be 5 patients, selected according to the predefined inclusion and non-inclusion criteria.Statistical Analysis:Data will be reported descriptively using mean, standard deviation, and percentages. Quantitative variables before and after intervention will be compared using paired t-test or Wilcoxon signed-rank test if the data are not normally distributed.Qualitative variables will be analyzed using McNemar or Chi-square tests. In the presence of multiple follow-up time points, Repeated Measures ANOVA or Linear Mixed Models will be applied.For biomarkers (NFL, IL-1β, IL-6, IL-10), logarithmic transformation or non-parametric tests will be used if the distribution is skewed. Correlations between biomarker changes and MRI/questionnaire findings will be assessed using Spearman correlation analysis.A p-value <0.05 will be considered statistically significant in all analyses. Bagheiat-allah University of Medical Sciences Approved 2026-05-18 Ethics committee of Baqiatallah University of Medical Sciences تهران ، میدان ونک ، خیابان ملاصدرا , خیابان شیخ بهایی جنوبی Tehran Tehran Iran (Islamic Republic of)