Intra-articular injections of allogeneic human adipose-derived mesenchymal progenitor cells in patients with symptomatic bilateral knee osteoarthritis: a Phase I pilot study
| Autor: | C. Thomas Vangsness, Liangjing Lu, Ping Ye, Hui Du, Li Zhang, Xiaoying Wang, Ryan Togashi, Suke Li, Chengxiang Dai, Chunde Bao, Yang Song |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Embryology Adolescent Visual analogue scale Biomedical Engineering Adipose tissue Pilot Projects Osteoarthritis Mesenchymal Stem Cell Transplantation Injections Intra-Articular Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Clinical endpoint Humans Transplantation Homologous Medicine Progenitor cell Adverse effect Aged 030203 arthritis & rheumatology 030222 orthopedics medicine.diagnostic_test business.industry Mesenchymal stem cell Mesenchymal Stem Cells Magnetic resonance imaging Middle Aged Osteoarthritis Knee Prognosis medicine.disease Anesthesia Female business Follow-Up Studies |
| Zdroj: | Regenerative Medicine. 15:1625-1636 |
| ISSN: | 1746-076X 1746-0751 |
| DOI: | 10.2217/rme-2019-0106 |
| Popis: | Aim: This study investigated the safety and clinical outcomes of expanded allogeneic human adipose-derived mesenchymal progenitor cells injected into patients with symptomatic, bilateral knee osteoarthritis. Design: In this single-site, randomized, double-blind, dose-ranging, Phase I study, patients were randomized to three treatment groups (low dose, 1 × 107 cells; medium dose, 2 × 107 cells; high dose, 5 × 107 cells). All patients received two bilateral intra-articular injections: week 0 (baseline) and week 3. The primary end point was adverse events within 48 weeks. Secondary end points were measured with Western Ontario and McMaster Universities Osteoarthritis index, visual analog scale, short form-36 at weeks 12, 24 and 48. Quantitative MRI measurements of cartilage volume were compared from baseline and week 48. Results: A total of 22 subjects were enrolled of which 19 (86%) completed the study. Adverse events were transient, including mild to moderate pain and swelling of injection site. Improvements from baseline were measured in the secondary end points. MRI assessments showed slight improvements in the low-dose group. Conclusion: Safety and improvements in pain and function after intra-articular injections of allogeneic human adipose-derived mesenchymal progenitor cells into arthritic patients was demonstrated. |
| Databáze: | OpenAIRE |
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