TOBI Faculty Publish Study on Adults Undergoing Autologous Stem Cell Therapy for Orthopedic Conditions
A Multi-center analysis of adverse events among 2,372 adult patients undergoing adult autologous stem cell therapy for orthopedic conditions:
As the use of mesenchymal stem cells (MSC’s) has increased in recent years, there has been concern in the medical community regarding potential risk for neoplastic changes in the treated regions. Although there is limited evidence to support such claims, research is continuing to investigate potential long term risks associated with BMC injections. Recently, Centeno et al completed prospective study of MSC use and adverse events over an extended follow up period. The study looked at over two thousand recipients of stem cell treatment for orthopedic pathology, including the spine, knee, hip, ankle/foot, hand/wrist, elbow and shoulder from 2005 to 2014.
The patients were followed prospectively at 1, 3, 6, and 12 months post BMC treatment, with annual follow up thereafter using an electronic medical record system. A total of over 3,012 procedures were completed on 2,372 patients, with follow up of approximately 2.2 years. After examining data over the full duration of follow up, only 7 cases reported neoplasms as a documented problem on their electronic record. According to the National Cancer Institute, the annual incidence of cancer in the U.S. population in 2011 was 0.44 % (438 cases per 100,000 individuals), and 0.78 % in adults 50–64 years. In comparison, this study observed a lower annual cancer rate (0.14 %) among the treated participants. Of the seven reported cases of neoplasm among the registry patients, none occurred at the site of implantation.
The study concluded that there was no clinical evidence to suggest that treatment with MSCs of any type was correlated with increased risk of neoplasm. Considering the large number of treated patients, age, and duration of follow up, isolated cases of malignancy could be expected. Although more research needs to be conducted to confirm the lack of adverse events, the results add to a growing volume of evidence suggesting MSC’s to be safe for the treatment of orthopaedic pathology.
Full study available at http://www.ncbi.nlm.nih.gov/pubmed/27026621