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Bone marrow concentrate injections considered safe treatment of orthopedic injuries
Common adverse events included post-procedure pain and pain due to degenerative joint disease.
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Patients who received bone marrow concentrate injections alone experienced the lowest rate of adverse events, according to study results.
Furthermore, a higher rate of adverse events in patients who received bone marrow concentrate injections plus adipose and cultured cells was explained by the nature of the therapy or longer follow-up.
“The take-home message is [by] using specific protocols we used that same day, cultured bone marrow stem cell procedures seemed to have a good safety profile,” Christopher J. Centeno, MD, of Centeno-Schultz Clinic, told Orthopedics Today.
Mesenchymal stem cell treatment
Centeno and his colleagues identified 2,372 patients with orthopedic injuries treated with one of three autologous mesenchymal stem cell protocols: same-day aspiration, isolation and reinjection procedure with bone marrow concentrate (SD); same-day aspiration, isolation and reinjection procedure with bone marrow concentrate plus adipose graft (AD); or culture expanded mesenchymal stem cells reimplanted weeks or months after bone marrow aspiration (CE). Researchers followed patients prospectively at 1 month, 3 months, 6 months, 12 months and annually thereafter.
Results showed 287 patients reported a total of 325 adverse events, with 1.5% of patients reporting serious adverse events. Researchers found the highest incidence of serious adverse events in the CE group (1.1/100 person years (PY)) compared with the AD (0.9/100 PY) and SD (0.4/100 PY) groups. Overall, independent adjudicators deemed 38 adverse events related to the procedures and 10 adverse events related to stem cells.
According to results, 93 patients reported post-procedure pain and 90 patients reported pain due to degenerative joint disease. The most frequent serious adverse event categories included neoplasm and neurologic and vascular events, with seven neoplasm cases, six serious neurologic events and five vascular events. No neoplasms were thought to be secondary to stem cell procedures, Centro noted.
Adverse events were more likely to be reported by patients in the AD and CE groups compared to the SD group, according to logistic regression modeling. Results showed post-procedure pain in the AD group and pain due to degenerative joint disease in the CE group attributed to the increase in adverse events. The risk of reporting adverse events increased among patients with a longer follow-up period, older age and female gender, and patients with a longer follow-up period and older age more commonly experienced serious adverse events.
Clinical implications
While the efficacy of stem cell therapies for orthopedic injuries have not yet been proven, Centeno and his research group have reported efficacy results in larger case series for knee, hip and shoulder osteoarthritis. However, all data should be reviewed by physicians offering this treatment before determining it appropriate for all patients, he added.
“You never know until you get in there and take a look at the data, meaning that this data was collected from more than just our site. It was collected from more than 20 different sites across the United States,” Centeno said. “While one doctor might feel like everything is safe, you never know what is happening with the other 19 sites until you take a look at the information.” – by Casey Tingle
- Reference:
- Centeno CJ, et al. Int Orthop. 2016;doi:10.1007/s00264-016-3162-y.
- For more information:
- Christopher J. Centeno, MD, can be reached at Centeno-Schultz Clinic, 403 Summit Blvd., Broomfield, CO 80021; email: centenooffice@centenoschultz.com.
Disclosure: Centeno reports he is the medical director of Regenexx.