Alejandra Garza‐Bedolla

AIM: Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra-articular injection of in vivo stimulated bone marrow SC could lead to an improvement in pain management and quality of life in patients with knee OA. METHOD: This was a prospective, open-label, phase I/II clinical trial to assess the safety and efficacy of a single intra-articular injection of autologous stimulated bone marrow stem cells (BM-SC) in patients with knee OA. Individuals of both genders older than 30 years with confirmed diagnosis of OA who signed informed consent were included in two groups: SC group received in vivo BM stimulation with subcutaneous administration of granulocyte colony stimulating factor (G-CSF). SC were obtained by BM aspiration and administered in a single intra-articular injection. The control group received exclusively oral acetaminophen. Visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index scores were performed at 1 week, 1 month and 6 months in both groups. This trial was registered in ClinialTrials.gov NCT01485198. RESULTS: A total of 61 patients were included. Socio-demographic characteristics, OA grades and initial scores were similar in both groups. The BM-SC group showed significant improvement in knee pain and quality of life during the 6-month follow-up. CONCLUSION: The study demonstrates feasibility and supports efficacy of a completely ambulatory procedure in treatment of knee OA.

=0.01; r= -0.60) posttreatment positively correlated with the enrichment of a putative BM stem cell population expressing the cluster of differentiation 133+ (CD133+) surface marker.

Clinical case description: A 61-year-old man with severe erectile dysfunction related to diabetes mellitus of long duration was treated through intracavernous stem cell application. Transplantation of autologous bone marrow stem cells through a single intracavernous injection was performed. Clinical response, Doppler ultrasound of the penis, and adverse events were evaluated during the 50-week follow-up. The highest clinical response was reported at week 12, but it diminished thereafter. At the end of follow-up, ultrasound identified the presence of neovascularization emerging from the cavernous arteries. Relevance: Numerous preclinical trials have demonstrated efficacy and safety, but there is insufficient clinical evidence showing promising results. Clinical implications: No adverse events were detected, and ultrasound revealed hemodynamic changes that were possibly related to the therapy. The source and dosage of stem cells, as well as subsequent therapeutic applications, pose questions that remain to be answered. Conclusions: Stem cell therapy for erectile dysfunction is a field of research that has sparked interest in numerous scientific groups, but clinical experience is still limited.