Three intra-articular injections of allogeneic umbilical cord-derived mesenchymal stromal cells in knee osteoarthritis: a phase-I clinical trial.

IF 3 4区医学 Q4 CELL & TISSUE ENGINEERING

Regenerative medicine Pub Date : 2026-01-01 Epub Date: 2026-02-27 DOI:10.1080/17460751.2026.2636683

Elaheh Khodadoust, Morteza Zarrabi, Elahe Afzal, Fatemeh Zamani, Masoumeh Nouri, Safdar Masoumi, Seyedeh Malihe Mahmoodi, Faeze Sharafi, Maedeh Alizadeh, Mohsen Emadedin, Massoud Vosough

{"title":"Three intra-articular injections of allogeneic umbilical cord-derived mesenchymal stromal cells in knee osteoarthritis: a phase-I clinical trial.","authors":"Elaheh Khodadoust, Morteza Zarrabi, Elahe Afzal, Fatemeh Zamani, Masoumeh Nouri, Safdar Masoumi, Seyedeh Malihe Mahmoodi, Faeze Sharafi, Maedeh Alizadeh, Mohsen Emadedin, Massoud Vosough","doi":"10.1080/17460751.2026.2636683","DOIUrl":null,"url":null,"abstract":"Purpose: This phase I clinical trial evaluated the safety and preliminary efficacy of three intra-articular injections of 20 × 106 allogeneic Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) in patients with Knee Osteoarthritis (OA) at a two-month interval.Methods: Six participants aged 40-70 years with Kellgren and Lawrence grade II-III were enrolled. They received three bilateral intra-articular injections of allogeneic UC-MSCs at two-month intervals. They were assessed for possible Adverse Events, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogue Scale (VAS), Short Form Health Survey, and Magnetic Resonance Imaging (MRI) over 12 months.Results: No serious adverse events occurred. Four participants (66%) reported at least one adverse event, most commonly transient injection-site pain or swelling. Exploratory analyses showed improvement in WOMAC scores from a median of 58.33 (IQR: 25-69.53) at baseline to 21.85 (IQR: 11.97-61.44) at 12 months, with pain and function improving in five patients (83%). VAS scores decreased by a median of 55% (IQR: -62.5 to -12.5). MRI showed no consistent structural changes, although mild tibial cartilage improvement was observed in two participants.Conclusion: Three intra-articular injections of allogeneic UC-MSCs appear to be safe and may provide functional benefits in patients with knee OA, supporting further investigation in larger, controlled trials.Clinical trial registration: https://irct.behdasht.gov.ir identifier is IRCT20211102052944N1.","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"21-33"},"PeriodicalIF":3.0000,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13011591/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regenerative medicine","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1080/17460751.2026.2636683","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/2/27 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"CELL & TISSUE ENGINEERING","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose: This phase I clinical trial evaluated the safety and preliminary efficacy of three intra-articular injections of 20 × 10⁶ allogeneic Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) in patients with Knee Osteoarthritis (OA) at a two-month interval.

Methods: Six participants aged 40-70 years with Kellgren and Lawrence grade II-III were enrolled. They received three bilateral intra-articular injections of allogeneic UC-MSCs at two-month intervals. They were assessed for possible Adverse Events, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogue Scale (VAS), Short Form Health Survey, and Magnetic Resonance Imaging (MRI) over 12 months.

Results: No serious adverse events occurred. Four participants (66%) reported at least one adverse event, most commonly transient injection-site pain or swelling. Exploratory analyses showed improvement in WOMAC scores from a median of 58.33 (IQR: 25-69.53) at baseline to 21.85 (IQR: 11.97-61.44) at 12 months, with pain and function improving in five patients (83%). VAS scores decreased by a median of 55% (IQR: -62.5 to -12.5). MRI showed no consistent structural changes, although mild tibial cartilage improvement was observed in two participants.

Conclusion: Three intra-articular injections of allogeneic UC-MSCs appear to be safe and may provide functional benefits in patients with knee OA, supporting further investigation in larger, controlled trials.

Clinical trial registration: https://irct.behdasht.gov.ir identifier is IRCT20211102052944N1.

查看原文本刊更多论文

三次关节内注射异体脐带间充质细胞治疗膝关节骨关节炎：一项i期临床试验

目的：本I期临床试验评估了3次关节内注射20 × 106异体脐带间充质间质细胞（UC-MSCs）治疗膝关节骨性关节炎（OA）患者的安全性和初步疗效，间隔2个月。方法：6名年龄40-70岁的Kellgren和Lawrence II-III级患者入组。他们每隔两个月接受三次双侧关节内注射同种异体UC-MSCs。对他们进行了12个月内可能的不良事件、西安大略省和麦克马斯特大学骨关节炎指数（WOMAC）、视觉模拟量表（VAS）、简短健康调查和磁共振成像（MRI）的评估。结果：未发生严重不良事件。四名参与者（66%）报告了至少一次不良事件，最常见的是短暂的注射部位疼痛或肿胀。探索性分析显示，WOMAC评分从基线时的中位数58.33 （IQR: 25-69.53）改善至12个月时的21.85 (IQR: 11.97-61.44)， 5名患者（83%）的疼痛和功能得到改善。VAS评分中位数下降55% （IQR: -62.5至-12.5）。MRI显示没有一致的结构改变，尽管在两名参与者中观察到轻微的胫骨软骨改善。结论：三次关节内注射同种异体UC-MSCs似乎是安全的，并可能为膝关节OA患者提供功能益处，支持更大规模的对照试验进一步研究。临床试验注册：https://irct.behdasht.gov.ir标识符：IRCT20211102052944N1。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Regenerative medicine 医学-工程：生物医学

CiteScore

4.20

自引率

3.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function*. Since 2006, Regenerative Medicine has been at the forefront of publishing the very best papers and reviews covering the entire regenerative medicine sector. The journal focusses on the entire spectrum of approaches to regenerative medicine, including small molecule drugs, biologics, biomaterials and tissue engineering, and cell and gene therapies – it’s all about regeneration and not a specific platform technology. The journal’s scope encompasses all aspects of the sector ranging from discovery research, through to clinical development, through to commercialization. Regenerative Medicine uniquely supports this important area of biomedical science and healthcare by providing a peer-reviewed journal totally committed to publishing the very best regenerative medicine research, clinical translation and commercialization. Regenerative Medicine provides a specialist forum to address the important challenges and advances in regenerative medicine, delivering this essential information in concise, clear and attractive article formats – vital to a rapidly growing, multidisciplinary and increasingly time-constrained community. Despite substantial developments in our knowledge and understanding of regeneration, the field is still in its infancy. However, progress is accelerating. The next few decades will see the discovery and development of transformative therapies for patients, and in some cases, even cures. Regenerative Medicine will continue to provide a critical overview of these advances as they progress, undergo clinical trials, and eventually become mainstream medicine.