A Pilot Prospective Randomized Controlled Trial to compare recovery following hip fracture arthroplasty using allogenic Wharton Jelly derived Stem cells versus Platelet Rich Plasma – Double-Blinded Study

Femoral neck fracture (FnF) within the older adult population represents a relevant socio-economic concern. It is associated with a substantially increased risk of death and major morbidity in older adults, with 33% cumulative one-year mortality rates. Post-traumatic and postoperative mobility impairment results in associated adverse events, such as thromboembolism and pneumonia.  Operative treatment of hip fractures is the only viable option in almost all cases in order to facilitate early mobilization, and to reduce the risk of complications associated with immobilization.

Patients treated with arthroplasty have the ability of full weight-bearing immediately after surgery, but nevertheless exhibit poor mobility, low quality of life, and high institutionalization rates. For the frail and often sarcopenic FnF patients, surgery results in a significant stress reaction as well as iatrogenic injury to the periarticular musculature of the hip.

Consequently, a high unmet clinical need exists to improve recovery following FnF surgery to enable the older adult patient cohort to regain physical function and return to activities of daily life. We therefore propose a randomized controlled trial of an intervention designed to enhance muscle performance and hence improve mobilization.

Therefore, the purpose of this study is to perform a Randomized Controlled Trial in order to determine efficacy, safety and tolerability of allogenic Wharton Jelly derived Stem cells in comparison with Platelet rich plasma (PRP).