来稿:陈琳  北京康复中心神经外科

Osteoarthritis  Cartilage. 2013 Oct;21(10):1465-73.

Safety of intra-articular cell-therapy with culture-expanded  stem cells in humans: a systematic literature review

Peeters CMLeijs MJReijman Mvan Osch GJBos PK

 

BACKGROUND:

An important goal of stem cell research in orthopaedics is to develop  clinically relevant techniques that could be applied to heal cartilage or joint  pathology. Stem cell treatment in orthopaedics for joint pathology is promising  since these cells have the ability to modulate different processes in the  various tissues of the joint simultaneously. The non life-threatening nature of  musculoskeletal system disorders makes safety of stem cell therapy a necessary  prerequisite.

OBJECTIVE:

To systematically review the literature and provide an overview of  reported adverse events (AEs) of intra-articular treatment with culture-expanded  stem cells in humans.

DESIGN:

A systematic literature search was performed in Pubmed, EMBASE, Web  of Science and CINAHL in February 2013. AEs were reported into three categories:  local/systemic, serious adverse event or AE (SAE/AE),  related/unrelated.

RESULTS:

3039 Potentially eligible articles were identified of which  eventually eight fulfilled our inclusion criteria. In total, 844 procedures with  a mean follow-up of 21 months were analysed. Autologous bone marrow-derived  mesenchymal stem cells (BM-MSCs) were used for cartilage repair and  osteoarthritis treatment in all included studies. Four SAEs were reported by the  authors. One infection following bone marrow aspiration (BMA) was reported as  probably related and resolved with antibiotics. One pulmonary embolism occurred  2 weeks after BMA and was reported as possibly related. Two tumours, both not at  the site of injection, were reported as unrelated. Twenty-two other cases of  possible procedure-related and seven of possible stem cell-product related  adverse events (AEs) were documented. The main AEs related to the procedure were  increased pain/swelling and dehydration after BMA. Increased pain and swelling  was the only AE reported as related to the  stem cell-product.

CONCLUSIONS:

Based on current literature review we conclude that application of  cultured stem cells in joints appears to be safe. We believe that with  continuous caution for potential side effects, it is reasonable to continue with  the development of articular stem cell therapies.

KEYWORDS:

Culture-expanded, Humans, Intra-articular, Safety,  Stem cells


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