Department of Biochemistry, S.C.B Medical College, Cuttack, Orissa, India.
Rejuvenation Res. 2009 Oct;12(5):359-66. doi: 10.1089/rej.2009.0872.
Bone marrow (BM)-derived mesenchymal stem cells (MSCs) represent a promising population for supporting new concepts in cellular therapy. This study was undertaken to assess the efficacy and feasibility of autologous BM-derived MSCs in the treatment of chronic nonhealing ulcers (diabetic foot ulcers and Buerger disease) of the lower extremities. A total of 24 patients with nonhealing ulcers of the lower limb were enrolled and randomized into implant and control groups. In the implant group, the patients received autologous cultured BM-derived MSCs along with standard wound dressing; the control group received only the standard wound dressing regimen, followed up for at least a 12-week period. Wound size, pain-free walking distance, and biochemical parameters were measured before therapy and at every 2-week interval following intervention. The implant group had significant improvement in pain-free walking distance and reduction in ulcer size as compared to those in the control group. In the implant group for Buerger disease, the ulcer area decreased from 5.04 +/- 0.70 cm(2) to 1.48 +/- 0.56 cm(2) (p < 0.001), whereas the pain-free walking distance increased from 38.33 +/- 17.68 m to 284.44 +/- 212.12 m (p < 0.001). In the diabetic foot ulcer group, the ulcer size decreased from 7.26 +/- 1.41 cm(2) to 2 +/- 0.98 cm(2) (p < 0.001) at 12 weeks. Mononuclear cells were cultured for a minimum of five passages and characterized by cell-surface markers showing CD90+, CD105+, and CD34(-). There was no significant alteration in the biochemical parameters observed during the follow-up period, indicating normal liver and renal function following intervention. Biopsy microsection of implanted tissues showed development of dermal cells (mainly fibroblasts), including mature and immature inflammatory cells. The study indicates that autologous implantation of BM-derived MSCs in nonhealing ulcers accelerates the healing process and improves clinical parameters significantly.
骨髓（BM）衍生的间充质干细胞（MSCs）为细胞治疗的新概念提供了有前途的治疗群体。本研究旨在评估自体 BM 衍生 MSC 治疗下肢慢性难愈性溃疡（糖尿病足溃疡和伯格病）的疗效和可行性。共纳入 24 例下肢难愈性溃疡患者，并随机分为植入组和对照组。植入组患者接受自体培养的 BM 衍生 MSC 联合标准创面敷料治疗；对照组仅接受标准创面敷料治疗，随访至少 12 周。在治疗前和干预后每 2 周测量创面大小、无痛行走距离和生化参数。与对照组相比，植入组的无痛行走距离明显改善，溃疡面积缩小。在伯格病植入组中，溃疡面积从 5.04 +/- 0.70 cm(2) 减少到 1.48 +/- 0.56 cm(2)（p < 0.001），而无痛行走距离从 38.33 +/- 17.68 m 增加到 284.44 +/- 212.12 m（p < 0.001）。在糖尿病足溃疡组中，溃疡面积在 12 周时从 7.26 +/- 1.41 cm(2) 减少到 2 +/- 0.98 cm(2)（p < 0.001）。至少传代培养 5 代的单核细胞，通过细胞表面标志物鉴定为 CD90+、CD105+、CD34-。在随访期间观察到的生化参数没有明显变化，表明干预后肝功能和肾功能正常。植入组织的活检微切片显示皮肤细胞（主要为成纤维细胞）的发育，包括成熟和不成熟的炎症细胞。研究表明，自体 BM 衍生 MSC 植入非愈合性溃疡可加速愈合过程，显著改善临床参数。
