Ganga Hospital Tissue Bank
The high demand for bone grafts for patients with polytrauma and complex limb reconstruction has meant that the Ganga hospital has had to establish a dedicated bone bank that will aid in reconstructive procedures.
The Tissue Bank at the Department of Orthopedics at the Ganga Hospital was launched from April 15th, 2008 with the technical assistance from Tissue Bank at the Tata Memorial Hospital Mumbai. Located within the hospital premises, it is a non-profit tissue bank aimed at providing cless-leading services. Entirely self-funded, it is only the third tissue bank in India to use Gamma irradiation as a method of sterilization (the other two are the Tata Memorial Hospital Tissue Bank and the Jodhpur National Defence Laboratory Tissue banks. The bank follows International Atomic Energy Agency (IAEA) standards followed by most of the Tissue banks in the world.
The bank is currently using well processed and gamma irradiated cortico cancellous bone allografts from tibial slices and femoral heads, bones from amputated stumps in various clinical conditions like comminuted fractures and Non-unions with bone loss of both upper & lower limbs, revision joint replacement surgeries and spinal fusion surgeries.
The Department of Tissue bank at Ganga hospital is headed by Dr. S Rajasekaran, Head and Director, Department of Orthopaedics & Spine surgery, two Scientific officers Dr P. Dhanasekara Raja and Dr. A. Devendra and one staff nurse.
Dr. S Rajasekaran was instrumental in the inception and establishment of Tissue bank. As a director, he is involved in the overall management of the Tissue bank, and all activities including issuing and control of documents, policy making, obtaining approval for procurement and for the compliance with standards.
Dr. P. Dhanasekara Raja, Consultant in Trauma and Arthroplasty surgery, has received the Degree of Diploma in Tissue banking from National university of Singapore, in 2008. He is involed in devising and validating the standard operative procedures and supervising the quality control management of Tissue bank.
Dr.A. Devendra, Registrar in the department of Othopaedics, trained in TATA Memorial hospital Tissue Bank, Mumbai and NUS TissueBank, Singapore, is involved in processing the bone tissues, packing, irradiation and despatch with Documentation, along with Staff nurse who is well trained in maintaining the sterility and environment control of Tissue Bank.
What is Tissue Bank?
A Tissue bank is a faculty that is capable of providing a complete spectrum of human tissues that have clinical usefulness as Fresh or Preserved allografts( grafts between different individuals of the same species).
A Tissue Bank aims at providing on demand, grafts that are of a useful and predictable function, and free from transmissible disease.
What does a Tissue Bank provide?
A Tissue bank serves as procurement and distribution centre of human allograft tissues such as Bone obtained from Live donors as well as amputated limbs. These are provided as non-viable allografts, preserved by freezing or freeze drying and sterilized by gamma irradiation. It also can provide soft tissue grafts like bone tendon bone grafts and ligaments.
What are the advantages of Tissue Bank?
- Provides improved patient care through tissue transplantation.
- Eliminates the trauma and morbidity associated with secondary surgical procedures used to harvest autografts (grafts from the recipient itself) which includes additional operation to harvest the graft, donor site pain, increased blood loss, increased operating time and limited graft quantity.
- Reduces hospital and medical costs.
- Avoids sacrifice of the patient’s normal structures.
- Provides in unlimited quantity any shape and size of allografts.
Who can be a donor to the Tissue bank?
The bone tissue is procured under sterile conditions in the operation theatre from patients who undergo total knee and hip joint replacements, Hemiarthroplasty, amputations due to or non salvageable vascular injuries and open injuries with Ganga open injury score above 14, after obtaining informed consent. Soon after procurement all the bone tissues are transferred to Deep freezer which maintains the temperature at -80degrees.
How is the Tissue Processed & Sterilized?
Sterilization is a necessity to prevent the transmission of disease and to prevent spoilage of the graft by micro organisms. This is done either by procuring the tissue under sterile conditions or by using a specific- sterilization process.
Tissues are stored in deep freezer for 4 weeks which reduces the immunogenecity. Then they are cut and washed with biofiltered water followed by pasteurization and alcohol therapy, terminal sterilization is by gamma irradiation. Pasteurization removes most vegetative bacteria, fungi and viruses including HIV. Alcohol therapy is effective against HIV, bacteria and spores.
In our Tissue Bank, processed allografts are irradiated by Gamma rays at a dose of 25 Kilo Gray units from Cobalt 60 source at Microtrol Sterilization Centre Pvt limited in Bangalore.
How is Tissue preserved?
Freeze- Drying / Deep Freezing:
The preservation of tissue is done by either Freeze Drying or Deep Freezing. Freeze drying removes at least 95% of the total water. This enables the biological material to be stored for long periods of time at room temperature, without any fear of detrimental enzymatic activity.
Biologically useful properties of the graft are also preserved.
How safe is this bone? Are there any Problems of rejection of the Graft or Antigenicity ?
Potential donors are evaluated and strict donor selection criterion are followed. All donors are screened for
- Anti HIV 1 & 2 Antibody and p24 antigen
- Anti HBS Antigen
- Anti HCV Antibody
Non-viable freeze dried allografts used for deep implantation do not demonstrate the classical allograft response characteristic of viable allografts. This phenomenon is thought to occur because of destruction of the transplantation antigen by the freeze drying process.
The risk of HIV Transmission:
- Blood transfusion : 1 in 2,50.000
- Deep frozen allografts: 1 in 1,667,600
- Lyophilized allografts : NIL
Recipients of bone allograft do not require immunosuppressive therapy, which in itself has potentially severe adverse affects.
How are grafts Stored ?
Frozen allografts are stored in Deep Freezing at -80 degrees temperature.
No special requirements like refrigeration, humidity control, sterile environment, etc. are necessary for storage of packaged , Freeze dried, irradiated allografts.
Such grafts may be kept indefinitely provided the integrity of the packaging is maintained.
Is it necessary to reconstitute the allograft before use?
All freeze – dried and frozen tissue requires some type of reconstitution.The Tissue Bank recommends that freeze dried and Frozen allografts should be reconstituted aseptically at 4 degrees temperature before use.
Sterile normal physiological saline or Hartmann Ringer – Lactate solution will suffice. An appropriate antibiotic solution may be used at the discretion of surgeon.
Any bone which requires shaping or drilling or is intended for load bearing purposes should be reconstituted for longer periods of time, approaching 24hrs prior to use. The length of reconstitution time may vary according to the type of tissue. Freeze – dried tissue may be somewhat brittle; however , the longer the tissue is reconstituted, the less brittle it becomes. Reconstitution instructions for tissues are sent along with each deposit
Grafts must be used within 24hours of complete reconstitution.
Once reconstituted no tissue may be returned to the Tissue bank.
What are the clinical uses of the allografts supplied by the Tissue Bank?
Freeze dried bone may be used to replace bone loss by stimulating bone healing. It acts as a matrix – like framework which aids and accelerates bone cells by new host cells.
Freeze dried bone allografts have provided clinically useful in the:
- Obliteration of cystic cavities.
- Repair of fresh fractures and fracture non-unions
- Arthrodesis of joints
- Reconstruction of skeletal defects following cancer, degenerative disease, trauma or congenital deformities
- Treatment of Scoliosis
- Repair of periodontal osseous defects.
- Repair of massive segmental defects including hemi joint defects.
What kind of record-keeping is maintained?
Like any other transplant service, bone banking needs strict quality control and meticulous recording of all the donors and the recipients. All the records pertaining to the bone bank are meticulously maintained and utmost care is taken to prevent any discrepancy in the data.
Bone transplantation is a rapidly growing and expanding field and has a significant impact on improving the quality of life for the recipient in need. Just as is the case with heart and kidney donation, efforts should be made to encourage more of cadaveric bone donations.
Awareness has to be created among the masses about the pressing need for more and more bone grafts for the reconstructions in the patients who otherwise will remain crippled and dependent.
Transplants of long bones or joints have a longterm success rate of 80%. Procedures using smaller pieces of tissue approach 100%.
Roughly 75% to 80% of recipients of massive osteochondral allografts following tumour resections achieve satisfactory function. A satisfactory result involves return of function, including motion, with little or no pain and without the needs for external aids for ambulation.
Significant complications include infection, nonunion at the osteosynthesis site and fracture through the substance of the graft. Chemotherapeutic agents have an adverse influence on allograft incorporation.