CONSENSUS RECOMMENDATION No studies meeting inclusion criteria evaluated intraarticular (IA) stem cell therapies for ankle osteoarthritis (OA). Efficacy, safety, optimal protocols, and appropriate patient selection cannot be determined. Patients should be counseled about investigational nature and lack of evidence.
Benefits/Harms:
Cannot be assessed. Stem cell therapies are marketed despite lack of rigorous evidence with significant heterogeneity in products, preparation methods, and protocols. Patients should be fully informed about investigational nature.
Cost Effectiveness/Resource Utilization:
IA stem cell therapy can typically range from approximately, $3,000-$10,000+, and is usually not covered by insurance. High cost and lack of evidence raise significant value concerns.
Acceptability:
Marketing drives demand despite lack of evidence. Ethical concerns exist regarding offering expensive therapies without established efficacy.
Feasibility:
Limited availability - requires specialized facilities, expertise, and regulatory compliance with significant variation in products and protocols.
Future Research:
High-priority, IRB-approved investigational therapies within clinical trials examining the standardization of cell preparation and protocols, dose-finding studies, identification of appropriate patient populations, long-term safety and efficacy data, mechanistic studies, cost-effectiveness analyses, and comparative effectiveness studies should be conducted.