From the Guidelines
StemWave should not be recommended as a primary treatment for any medical condition at this time. The current evidence base, as highlighted by the 2019 consensus recommendations from the American Academy of Orthopaedic Surgeons 1, emphasizes the need for high-quality clinical trials to evaluate the efficacy and safety of biologic therapies, including stem cell therapy, for musculoskeletal conditions. While knee osteoarthritis is identified as a condition with substantial and progressive morbidity, the use of stem cell therapy for this condition is not supported by strong evidence.
Key considerations for the use of biologic therapies include:
- The lack of standardization in product characterization and clinical research
- The need for minimum standards for product characterization and clinical research
- The importance of establishing high-quality patient registries and biorepository-linked registries for postmarket surveillance and quality assessments
In contrast, other evidence, such as the treatment recommendations for Waldenström's macroglobulinemia 1, highlights the importance of evidence-based treatments with proven efficacy for specific conditions. This study provides guidance on treatment options, including ibrutinib, ofatumumab, and stem cell transplantation, but does not support the use of stem cell therapy as a primary treatment for other conditions.
Given the current state of evidence, patients should pursue established, evidence-based treatments with proven efficacy for their specific conditions, rather than considering stem cell therapy as a primary treatment option. Any consideration of stem cell therapy should occur only after consultation with qualified healthcare providers who can evaluate the appropriateness based on individual medical circumstances.
From the Research
Conditions for StemWave (Stem Cell Therapy) as Primary Treatment
- Diabetic foot ulcers (DFU) are a potential condition for StemWave therapy, as evidenced by studies 2, 3, 4, 5, 6
- DFU is a severe complication of diabetes mellitus, often resulting in limb amputation, and stem cell therapy has shown promise in treating this condition 2, 3, 4
- Stem cell therapy can improve chronic wound healing via different mechanisms, including promoting angiogenesis, secreting paracrine factors, controlling inflammation, and regulating immunity 4, 6
- The use of stem cells, such as mesenchymal stem cells, adipose tissue-derived mesenchymal stem cells, and bone marrow mesenchymal stem cells, has shown efficacy in treating DFU 2, 4, 5
- However, further research is needed to establish standardized treatment protocols and determine the most effective cell type, dosage, and mode of administration for DFU treatment 2, 4, 6
Key Factors in DFU Treatment
- Ischemia, neuropathy, and neuro-ischemia are underlying factors of diabetic foot ulcers, and stem cell therapy can help address these factors 2, 4
- The route and protocol for stem cell administration, as well as concomitant use of other therapies, can impact the effectiveness of treatment 4
- Granulocyte-colony stimulating factor and angioplasty have been used in conjunction with stem cell therapy to enhance treatment outcomes 4
- Photobiomodulation therapy has also shown promise in treating DFU, but further research is needed to standardize therapeutic protocols 5