Garay-Mendoza Domingo, Villarreal-Martínez Laura, Garza-Bedolla Alejandra, Pérez-Garza Daniela M, Acosta-Olivo Carlos, Vilchez-Cavazos Felix, Diaz-Hutchinson Cesar, Gómez-Almaguer David, Jaime-Pérez José C, Mancías-Guerra Consuelo
Traumatology and Orthopaedics Service, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León, Monterrey, México.
Hematology Service, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León, Monterrey, México.
Int J Rheum Dis. 2018 Jan;21(1):140-147. doi: 10.1111/1756-185X.13139. Epub 2017 Jul 27.
Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra-articular injection of in vivo stimulated bone marrow SC could lead to an improvement in pain management and quality of life in patients with knee OA.
This was a prospective, open-label, phase I/II clinical trial to assess the safety and efficacy of a single intra-articular injection of autologous stimulated bone marrow stem cells (BM-SC) in patients with knee OA. Individuals of both genders older than 30 years with confirmed diagnosis of OA who signed informed consent were included in two groups: SC group received in vivo BM stimulation with subcutaneous administration of granulocyte colony stimulating factor (G-CSF). SC were obtained by BM aspiration and administered in a single intra-articular injection. The control group received exclusively oral acetaminophen. Visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index scores were performed at 1 week, 1 month and 6 months in both groups. This trial was registered in ClinialTrials.gov NCT01485198.
A total of 61 patients were included. Socio-demographic characteristics, OA grades and initial scores were similar in both groups. The BM-SC group showed significant improvement in knee pain and quality of life during the 6-month follow-up.
The study demonstrates feasibility and supports efficacy of a completely ambulatory procedure in treatment of knee OA.
骨关节炎（OA）的治疗主要是对症治疗。最近，干细胞（SC）已被用于寻找最佳治疗方法。我们决定进行一项对照临床试验，以确定单次关节内注射体内刺激的骨髓干细胞是否能改善膝骨关节炎患者的疼痛管理和生活质量。
这是一项前瞻性、开放标签的I/II期临床试验，旨在评估单次关节内注射自体刺激骨髓干细胞（BM-SC）对膝骨关节炎患者的安全性和有效性。年龄超过30岁、确诊为OA且签署知情同意书的男女患者被纳入两组：SC组接受皮下注射粒细胞集落刺激因子（G-CSF）进行体内骨髓刺激。通过骨髓穿刺获取干细胞，并进行单次关节内注射。对照组仅接受口服对乙酰氨基酚。两组均在1周、1个月和6个月时进行视觉模拟评分以及西安大略和麦克马斯特大学骨关节炎指数评分。该试验已在ClinicalTrials.gov上注册，注册号为NCT01485198。
共纳入61例患者。两组的社会人口统计学特征、OA分级和初始评分相似。BM-SC组在6个月的随访期间膝关节疼痛和生活质量有显著改善。
该研究证明了一种完全非卧床治疗方法治疗膝骨关节炎的可行性并支持其有效性。
