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Bone-Marrow Derived Stem Cell Injections for Wound Healing and Tissue Rejuvenation: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines

Last updated: May 30, 2017
Project Number: RC0884-000
Product Line: Rapid Response
Research Type: Devices and Systems
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of bone marrow-derived stem cell (BMDSC) injections for wound healing or tissue rejuvenation in orthopedic and trauma patients?
  2. What is the cost-effectiveness of BMDSC injections for wound healing or tissue rejuvenation in orthopedic and trauma patients?
  3. What are the evidence-based guidelines regarding the use of BMDSC injections for wound healing or tissue rejuvenation in orthopedic and trauma patients?

Key Message

Overall, there were an insufficient number of high quality studies that specifically looked at the effectiveness of BMDSC injection in various trauma, injury, or other orthopedic conditions. Among the four relevant systematic reviews identified, two reported improved clinical, functional and safety outcomes in patients with knee osteoarthritis (OA) by measuring knee and joint functions, quality of life, cartilage growth, pain and other subjective parameters as well as any adverse events (AE). Two other systematic reviews showed that among patients with osteonecrosis of the femoral head (ONFH), BMDSC injection can lead to a reduction in pain and other clinical symptoms, osteonecrosis volume, progression of disease and other radiological outcomes, and the need for total hip replacement (THR). However, two of the included systematic reviews lacked methodological rigor and adequate reporting. In addition, the inclusion of several non-comparative studies and heterogeneous mode of BMDSC implantation, outcomes assessed, and methodologies of the component studies are important considerations. Two high-quality randomized clinical trials showed that following injection of BMDSC, patients with a range of knee injuries had a significant improvement in their clinical and radiological outcomes. In addition, cell therapy was not associated with any serious AEs and no or few mild to moderate AEs as reported from these studies, in addition to a phase I safety trial.The guideline included in this report concluded that there is insufficient high quality evidence that injection of cultured BMDSC is effective in the remedy of delayed union or nonunion of long bone fractures. In addition, owing to the differences in BMDSC harvesting and culturing as well as measurement of relevant outcomes across studies, the authors recommended against its use in clinical practice.