Allograft Possibilities

Orthopedic Allograft Safety

Strict Donor Screening and Tissue Testing

The Joint Restoration Foundation requires a comprehensive physical assessment, and a complete medical and social history to identify and eliminate donors that are at high risk of being carriers of communicable diseases. All donors have been screened for evidence of infectious disease, degenerative neurological disease, high-risk behaviors and recent surgical procedures. Tissue allografts are cultured for microbiological testing, and a blood sample is obtained for serological testing.
The donor must test negative or non-reactive to tests for:

• Hepatitis B Surface Antigen (HBsAg)

• Hepatitis B Core IgG/IgM Antibody (HBc)

• Antibody to Human Immunodeficiency Virus 1/2 (HIV 1/2)

• Antibody to Human T-Cell Lymphotropic Virus Type I & II (HTLV I/II)

• Antibody to Hepatitis C (HCV)

• Rapid Plasma Reagin or Serologic Test for Syphilis (RPR or STS)

• HIV-1 HCV NAT using Transcription-Mediated Amplification (HIV-1/HCV NAT via TMA) or HIV DNA using Polymerase Chain Reaction (HIV DNA by PCR)

During tissue recovery and processing, four separate microbiological tests are performed to screen tissue for bacteria. After passing screening, the tissue is processed into transplantable allografts.

Aseptic Processing (processing is NOT validated)

All tissue goes through an initial aseptic cleansing process in a controlled environment; including ISO Class 5 clean rooms with HEPA filtered air. State-of-the-art cleaning and processing eliminates bone marrow, blood elements, lipids and bacteria while maintaining the biomechanical integrity of the allografts. Microbial testing is performed on final products by a CLIA-certified lab to assure the safety of the allograft for transplantation in accordance with CLIA and AATB regulations.

Sterility Assurance

The final processing step is to assure the final sterility of each frozen soft tissue allograft. All frozen joint repair allografts undergo a low dose, low temperature sterilization process that produces allografts with a Sterility Assurance Level (SAL) of 10-6. This is the sterility standard required by the FDA for medical device implants and is achieved without damaging the required biological components of the allograft.

Fresh Osteochondral Allograft Safety

All fresh osteochondral allografts go through the rigorous screening procedure as all of the other allografts produced by AlloSource for the Joint Restoration Foundation. The primary distinction is that fresh allografts cannot be sterilized because the sterilization methods available today would also damage the healthy cartilage cells necessary for a successful, long-term clinical outcome and destroy the functionality of the allograft. Once processed and prepared for transplantation, fresh Osteochondral allografts are stored at refrigerated temperatures.