Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results.

Wrist osteoarthritis (OA) is one of the most common conditions encountered by hand surgeons with limited efficacy of non-surgical treatments. The purpose of this study is to describe the Platelet-Rich Plasma (PRP) mixed-microfat biological characteristics of an experimental Advanced Therapy Medicinal Product (ATMP) needed for clinical trial authorization and describe the clinical results obtained from our first three patients 12 months after treatment (NCT03164122). Biological characterization of microfat, PRP and mixture were analysed in vitro according to validated methods. Patients with stage four OA according to the Kellgren Lawrence classification, with failure to conservative treatment and a persistent daily painful condition >40 mm according to the visual analog scale (VAS) were treated. Microfat-PRP ATMP is a product with high platelet purity, conserved viability of stromal vascular fraction cells, chondrogenic differentiation capacity in vitro and high secretion of IL-1Ra anti-inflammatory cytokine. For patients, the only side effect was pain at the adipose tissue harvesting sites. Potential efficacy was observed with a pain decrease of over 50% (per VAS score) and the achievement of minimal clinically important differences for DASH and PRWE functional scores at one year in all three patients. Microfat-PRP ATMP presented a good safety profile after an injection in wrist OA. Efficacy trials are necessary to assess whether this innovative strategy could delay the necessity to perform non-conservative surgery.

Intra Articular Injection of Autologous Microfat and Platelets-Rich Plasma in the Treatment of Wrist Osteoarthritis: A Pilot Study.

No injection treatment has been proven to be effective in wrist osteoarthritis. When conservative measures fail, its management involves invasive surgery. Emergence of biotherapies based on adipose derived stem cells (ADSC) offers promising treatments for chondral degenerative diseases. Microfat (MF) and platelets-rich plasma (PRP) mixture, rich in growth factors and ADSC could be a minimally invasive injectable option in the treatment of wrist osteoarthritis. The aim of this uncontrolled prospective study was to evaluate the safety of a 4 mL autologous MF-PRP intra-articular injection, performed under local anesthesia. The secondary purpose was to describe the clinical and MRI results at 12 months of follow-up. Patients' data collected were: occurrence of adverse effects, Visual analog scale (VAS), Disabilities of the Arm, Shoulder and Hand score (DASH) and Patient-Rated Wrist Evaluation (PRWE) scores, wrist strength, wrist range of motion and 5-level satisfaction scale. No serious adverse event was recorded. A statistically significant decrease in pain, DASH, PRWE and force was observed at each follow-up. Our preliminary results suggest that intra-articular autologous MF and PRP injection may be a new therapeutic strategy for wrist osteoarthritis resistant to medical symptomatic treatment prior to surgical interventions.

Free vascularized medial femoral condyle corticoperiosteal flap with non-vascularized iliac crest graft for the treatment of recalcitrant clavicle non-union.

Clavicle non-union is a challenging problem. Open reduction with internal fixation and autologous bone grafting is usually the first line treatment. In case of failure, the medial femoral condyle corticoperiosteal flap in association with a non-vascularized bone graft is one of the therapeutic options, which is well adapted to the clavicle anatomical characteristics. We performed a retrospective study of all patients treated with this technique in our department. Between 2014 and 2017, five patients with recalcitrant post traumatic clavicle non-unions received this surgical treatment. The average nonunion time period was 50.2 month (range 10 to 108 months), and the mean defect length was 3.4 cm (between 2 and 5 cm), defects were all located in the medial third of the clavicle Three patients achieved full consolidation with an average time of consolidation of 8,7 months (range 6 to12 months). Patients with radiological consolidation had better functional improvement and pain reduction with an average DASH score improved from 53,6 before surgery to 19,6 after consolidation (at the last follow up visit). There was one donor site complications (hematoma). The medial femoral condyle corticoperiosteal flap with non-vascularized iliac crest graft is a good option for the management of recalcitrant clavicle non-union, especially when the bone defect is small.