Intra-articular knee implantation of autologous bone marrow-derived mesenchymal stromal cells in rheumatoid arthritis patients with knee involvement: Results of a randomized, triple-blind, placebo-controlled phase 1/2 clinical trial
| Autor: | Neda Jaroughi, Mohammad Chehrazi, Mohsen Emadedin, Narges Labibzadeh, Soura Mardpour, Hossein Baharvand, Maryam Niknejadi, Nasser Aghdami, Seyyedeh Esmat Hosseini, Soraya Shadmanfar, Fatemeh Abbasi Kakroodi, Vajiheh Azimian, Tina Bolurieh, Farhad Gharibdoost |
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| Rok vydání: | 2017 |
| Předmět: |
musculoskeletal diseases
0301 basic medicine Adult Male Cancer Research medicine.medical_specialty WOMAC Knee Joint Immunology Population Arthritis Bone Marrow Cells Osteoarthritis Placebo Mesenchymal Stem Cell Transplantation Injections Intra-Articular Arthritis Rheumatoid Placebos 03 medical and health sciences 0302 clinical medicine Double-Blind Method medicine Immunology and Allergy Humans education Genetics (clinical) Aged Bone Marrow Transplantation Transplantation education.field_of_study business.industry Mesenchymal Stem Cells Cell Biology Middle Aged Osteoarthritis Knee medicine.disease Surgery Clinical trial 030104 developmental biology Treatment Outcome Oncology Tolerability 030220 oncology & carcinogenesis Rheumatoid arthritis Female business |
| Zdroj: | Cytotherapy. 20(4) |
| ISSN: | 1477-2566 |
| Popis: | Background In this study, we intend to assess the safety and tolerability of intra-articular knee implantation of autologous bone marrow–derived mesenchymal stromal cells (MSCs) in patients with rheumatoid arthritis (RA) and to determine the preliminary clinical efficacy data in this population. The trial registration numbers are as follows: Royan Institute Ethics Committee: AC/91/1133; NCT01873625. Methods This single-center, randomized, triple-blind, placebo-controlled phase 1/2 clinical trial randomized RA patients with knee involvement to receive either an intra-articular knee implantation of 40 million autologous bone marrow–derived MSCs per joint or normal saline (placebo). Patients were followed up for 12 months to assess therapy outcomes. Results A total of 30 patients, 15 in the MSC group and 15 in the placebo group, enrolled in this study. There were no adverse effects reported after MSC administration or during follow-up. Patients who received MSCs had superior findings according to the Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analogue scale (VAS), time to jelling and pain-free walking distance. However, this improvement could not be significantly sustained beyond 12 months. The MSC group exhibited improved standing time (P = 0.01). In addition, the MSCs appeared to contribute to reductions in methotrexate and prednisolone use. Conclusion Intra-articular knee implantation of MSCs appeared to be safe and well tolerated. In addition, we observed a trend toward clinical efficacy. These results, in our opinion, have justified the need for further investigations over an extended assessment period with larger numbers of RA patients who have knee involvement. |
| Databáze: | OpenAIRE |
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