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IRCT20160704028786N3 IRCT 2026-06-06 Royan Institute Safety and feasibility of intra-articular injection of mesenchymal stromal cells in knee osteoarthritis The Safety & Feasibility Study of Intra-Articular Transplantation of Wharton’s Jelly-Derived Mesenchymal Stromal Cells in Patients with Knee Osteoarthritis: Clinical Trial Phase I/IIa 2026-08-07 anticipated 20 Recruiting https://irct.ir/trial/89645 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation method Participants who meet the eligibility criteria and provide informed consent will be assigned in a 1:1 ratio to either the MSC intervention group or the control group using a computer-generated random sequence. Sequence generation The random allocation sequence will be created by an independent statistician who is not involved in participant recruitment, assessment, treatment administration, or data analysis. Randomization will be performed using a block randomization method with variable block sizes to maintain group balance throughout the enrollment period. Implementation After confirming eligibility and obtaining informed consent, the study coordinator will assign the participant to the next available allocation according to the concealed randomization list. The person enrolling participants will not have access to the random sequence. Stratification If applicable, randomization may be stratified by key prognostic factors such as: Baseline radiographic severity of knee OA Study center Age group or sex If no stratification is planned, this should be explicitly stated, Blinding description: This clinical trial utilizes a single-blind design in which the statistical analyst remains blinded to the treatment allocation, while participants, the administering clinician, and the clinical outcome assessors are aware of the intervention. To maintain the integrity of the statistical analysis, the randomization sequence is generated by an independent statistician, and treatment assignments—comprising either Wharton’s jelly–derived mesenchymal stromal cells or high molecular weight Hyaluronic Acid—are allocated to participants upon enrollment. All clinical data, including VAS scores, WOMAC indices, physical examination findings, and adverse events, are recorded and entered into the database by the clinical team without blinding. Prior to statistical evaluation, the data is pseudonymized using neutral group identifiers (e.g., Group 1 and Group 2), ensuring that the data analyst remains blinded to the nature of the interventions during the analysis phase. Unblinding and the subsequent reconciliation of the group identifiers with the actual interventions will occur only after the primary statistical analysis is finalized and the study database is officially locked. 1-2 Knee Osteoarthritis. Intervention 1: Intervention group: In this group, 20 million Wharton’s jelly-derived mesenchymal stromal cells suspended in 3 mL of sterile normal saline (0.9% sodium chloride), together with 10% albumin serum, will be administered to the patient. This cellular product is prepared under standard conditions in an Cell Processing Facility and is approved with respect to cell viability, sterility, and phenotypic characteristics.Method of administration: The injection will be performed as a single administration (single-dose) under sterile conditions by an experienced specialist physician into the joint space of the affected knee. Intervention 2: Control group: In this group, patients will receive a single intra-articular injection of high-molecular-weight sodium hyaluronate. The injectable material consists of a sterile high-molecular-weight sodium hyaluronate preparation suitable for intra-articular administration, which will be used at the standard approved dose for intra-articular use in knee osteoarthritis. The injection will be administered intra-articularly into the affected knee in a single session, under sterile conditions, by a qualified physician experienced in intra-articular knee injections. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Alireza Beheshti maal
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2356 2211 alirezabeheshtimaal@gmail.com Royan Institute scientific Hossein Baharvand
Royan Institute for Stem cells Biology and Technology- Royan Institute- Hafez St.- Northern Banihashem Ave.- Resalat Exp Way
Tehran Iran (Islamic Republic of) 16635148 +98 21 2230 6485 baharvand@royaninstitute.org Royan Institute Iran (Islamic Republic of) Age between 18-70 years Both Sexes Grade 2 and 3 Kolgren osteoarthritis of the knee joint (diagnosis by standing knee radiograph) Malalignment of the knee joint less than 20 degrees. Diagnosis by radiography (three joint view) Visual analog scale of the patient greater than or equal to 4 Failure to respond to standard treatment in the past 3 months Written informed consent 18 years 70 years Both Body mass index greater than 35 A history of recent surgery or imminent need for joint replacement History of intra-articular corticosteroid or hyaluronic acid injection within the past 3 months Any coagulopathy or use of anticoagulant medications Any need for corticosteroid use Immunocompromised state Active malignancy or history of malignancy in the last 5 years Severe Allergy to biologic/protein products Pregnancy or breastfeeding Concomitant participation in another clinical trial Active systemic or knee joint infection Substance use disorder Any uncontrolled concomitant disease M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: In this group, 20 million Wharton’s jelly-derived mesenchymal stromal cells suspended in 3 mL of sterile normal saline (0.9% sodium chloride), together with 10% albumin serum, will be administered to the patient. This cellular product is prepared under standard conditions in an Cell Processing Facility and is approved with respect to cell viability, sterility, and phenotypic characteristics.Method of administration: The injection will be performed as a single administration (single-dose) under sterile conditions by an experienced specialist physician into the joint space of the affected knee. Control group: In this group, patients will receive a single intra-articular injection of high-molecular-weight sodium hyaluronate. The injectable material consists of a sterile high-molecular-weight sodium hyaluronate preparation suitable for intra-articular administration, which will be used at the standard approved dose for intra-articular use in knee osteoarthritis. The injection will be administered intra-articularly into the affected knee in a single session, under sterile conditions, by a qualified physician experienced in intra-articular knee injections. Safety: Safety is defined as the frequency, type, severity, and suspected relatedness of adverse events associated with intra articular injection of mesenchymal stromal cells. All adverse events (AEs) and serious adverse events (SAEs) will be recorded from the time of the first infusion until the end of the follow-up period and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Timepoint: One week, three months and six months after the intervention. Method of measurement: Safety and adverse events are assessed through physical examination, history taking, and questionnaire. Efficacy via the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): defined as “the change in the knee WOMAC score from study entry/baseline to the specified follow-up time point(s) after the intervention.”. Timepoint: The study assesses the effectiveness of the intervention on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at the beginning of the study and 3 months and 6 months after the intervention. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire is used. Efficacy based on the Visual Analogue Scale (VAS) after injection: defined as “the change in the knee joint pain VAS score from study entry (baseline) to the specified follow-up time point(s) after the intervention.”. Timepoint: In the study, the effectiveness of the intervention on the Visual Analogue Scale (VAS) criterion is assessed at the beginning of the study and 3 months and 6 months after the intervention. Method of measurement: Visual Analogue Scale (VAS) is performed using a graduated scale. Efficacy based on the 6‑Minute Walking Test (6MWT) after injection: defined as “the change in the distance walked during the 6‑minute walk test (in meters) from study entry (baseline) to the specified follow-up time point(s) after the intervention.”. Timepoint: In the study, the effectiveness of the intervention on the 6 Minute Walking Test (6MWT) criterion is assessed at the beginning of the study and 3 months and 6 months after the intervention. Method of measurement: The distance the patient walks in 6 minutes is recorded. Efficacy based on MRI criteria (cartilage and surrounding periarticular structures) after injection: defined as “the change in knee joint MRI findings (including cartilage-related changes and other articular/periarticular structural changes, assessed according to the predefined scoring criterion/system specified in the study protocol) from study entry (baseline) to the specified post-intervention follow-up time point(s).”. Timepoint: In the study, the effectiveness of the intervention will be assessed at the baseline and 6 months after intervention. Method of measurement: Assessment will be done using Magnetic Resonance Imaging (MRI) and scoring will be done with the MRI Osteoarthritis Knee Score (MOAKS). Royan Institute Approved 2025-11-19 Research Ethics Committee of Royan Institute No. 1270, Central office of the Academic Center for Education, Culture and Research, opposite the main door of the University of Tehran, Enghelab St. Tehran Tehran Iran (Islamic Republic of)