The tissues in the Amnion Suspension Allograft (ASA) are collected from fully consented mothers undergoing scheduled caesarean section births of full-term healthy babies. Donor mothers are tested for relevant communicable diseases by an FDA-registered laboratory. Donor mothers and babies are tested prior to the product release. The ASA is cryopreserved to maintain tissue integrity and is delivered in a validated container that maintains -70∞ to -90∞C temperature till use. ReNu has a well-defined manufacturing process and quality controls and is a current (BLA) Biological License Approval candidate.
In an initial safety pilot clinical study evaluating an Amnion Suspension Allograft (ASA) for osteoarthritis (OA), six patients with KL grade 3 knee OA were enrolled. Each patient had a single knee injection of cryopreserved ASA. Patients were followed at 1 week, 2 weeks, 3 months, 6 months, and 12 months post injection; no adverse events were reported. The patients were monitored at multiple time points for safety with white blood cell count, C-reactive protein (CRP), erythrocyte sedimentation rate (ERS), and immunologic panel with no concerning changes identified.
(See publication – Cryopreserved amniotic suspension for the treatment of knee osteoarthritis. J Knee Surg 2016;29(06):443-450)