It's the Biology Orthopods! Heralding a Reconstructive Revolution Through Musculoskeletal Tissue Banks (MSTB) in India.

Background: A tissue bank is an establishment that aids in retrieval, processing, storage, and distribution  of human tissue for transplantation. For many years, such banks have been dispensing tissue to orthopaedic surgeons, performing reconstructive surgeries. Methodology: The retrieval, preparation, and delivery of musculoskeletal tissue used for transplantation is an intricate process  involving varying practices among different musculoskeletal tissue banks. Results: Musculoskeletal allografts are used in various orthopaedic surgeries ranging from primary bone defects, trauma, and carcinoma to congenital disabilities. Every decade brings in paradigm shifts and new hope for treating challenging cases with the aid of newer devices and materials. Conclusion: This review article outlines various technical, regulatory and quality enhancement steps involved in tissue banking. Also, it discusses the road ahead and the research avenues for developing novel allograft products with the synergy of tissue banks and clinicians. Supplementary Information: The online version contains supplementary material available at 10.1007/s43465-022-00661-0.

Regulatory aspects of tissue donation, banking and transplantation in India.

Amendments to India's Transplantation of Human Organs Act, 1994, have established the legality of tissue donation and transplantation from deceased donors and the conditions under which they are permitted. The amended Act, now known as The Transplantation of Human Organs and Tissues Act, 1994, seeks to prevent the commercialization of tissue donation and to guarantee the safety of indigenous allografts. Registration of tissue banks, compliance with national standards and the appointment of transplant co-ordinators in hospitals registered under the Act are now mandatory. A national registry and Regional and State networks for donation and transplantation of tissues have been introduced. Despite the amendments a few anomalies of the principal Act persist as some of the differences between tissue and organ donation and transplantation have been overlooked. These include the possibility of skin donation in locations other than hospitals; the donation of medical and surgical tissue residues which does not pose any risk to the living donor; the non-requirement for compatibility between donor and recipient; the delayed time factor between tissue donation and transplantation which makes identification of a recipient at the time of donation impossible; and the easy availability of alternatives to tissues which make waiting lists redundant for many tissues. Rules for the implementation of the amended Act were framed in 2014 but like the Act must be adopted by the State health assemblies to become universally applicable in the country.

Comparative study of indigenously prepared and imported, demineralized, freeze-dried, irradiated bone allograft in the treatment of periodontal infrabony defects.

Demineralized freeze-dried bone allograft (DFDBA) has been used extensively in periodontal therapy. Questions have been raised however, about the osteogenic potential of the variety of grafts available. In India the cost factor is another important consideration. The aim of this study therefore was to evaluate the clinical efficiency of the low priced, indigenously prepared DFDBA obtained from the Tata Memorial Hospital (TMH) Tissue Bank, in periodontal regeneration in infrabony periodontal defects, as compared to DFDBA obtained from the Pacific Coast Tissue Bank (DEMBONE). The latter was used as the control. 16 patients with bilaterally similar periodontal infrabony defects were selected, and randomly allotted to the test and control groups. At baseline, using standardized protocol, recession, probing depths (PD), and clinical attachment levels (CAL) were measured, following which periodontal surgery was carried out, with placement of the respective graft materials. Patients were recalled after 6 months for re-assessment. Statistically significant improvement was obtained for PD reduction and CAL gain for both groups (p < 0.05). However, no significant difference was observed between the test and control groups. It was therefore concluded that both the materials from different tissue banks are equally effective clinically, with the test material being additionally cost effective.

A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in India.

The banking of tissues such bone and skin began in India in the 1980s and 1990s. Although eye banking started in 1945 there was little progress in this field for the next five decades. As part of the IAEA/RCA program to use ionising radiation for the sterilisation of biological tissues in Asia and the Pacific Region, the Tata Memorial Hospital (TMH) in 1986 decided to set up a tissue bank in Mumbai funded by the Government of India. The TMH Tissue Bank became operational in January 1988, and stands as a pioneering effort in the country to provide safe, clinically useful and cost-effective human allografts for transplantation. It uses the IAEA International Standards on Tissue Banking. All the grafts are sterilised terminally by exposure to a dose of 25 kGy of gamma radiation, which has been validated as recommended by the IAEA Code of Practice for the Radiation Sterilisation of Tissues Allografts: Requirements for Validation and Routine Control. The TMH Tissue Bank is registered with the Maharashtra State Health Authorities, and in May 2004, it became India's first Tissue Bank to receive ISO 9001:2000 certification of its Quality Management System. From 1989 to September 2007, the TMH Tissue Bank has supplied 11,369 allografts to 310 surgeons operating in 69 hospitals in Mumbai and 56 hospitals in other parts of India. These numbers have been limited by difficulties with the retrieval of tissues from deceased donors due to inadequate resources and tissue donation policies of hospitals. As the Government of India representative in the IAEA program, the TMH Tissue Bank has promoted and co-coordinated these activities in the country and the development of tissue banks using radiation sterilisation of tissue grafts. Towards this end it has been engaged in training personnel, drawing up project proposals, and supporting the establishment of a Tissue Retrieval Centre in Mumbai. Currently it networks with the Zonal Transplant Co-ordination Centre of the Government of Maharashtra, and the newly instituted National Deceased Donor Transplantation Network, which will work with the Government of India to set up rules and regulations for organ and tissue donation and transplantation.

Use of banked tissue in plastic surgery.

The availability of safe and reliable, banked tissues in India has enabled the use of human bone allografts as a viable alternative to autografts in reconstructive surgery. Lyophilised, irradiated bone grafts were used in 2 cases of rhinoplasty, a case of hemifacial atrophy, and as a chin implant.In the patient with revision rhinoplasty the rib graft was resorbed. The patient with hemifacial atrophy developed seroma and infection in the zygomatic and infraorbital area and the rib graft had to be removed. The graft from the same rib that was placed over the mandible was retained well and incorporated completely. The iliac crest cortico-cancellous grafts did well in the second case of augmentation rhinoplasty and in the augmentation of chin.The primary objective of reconstructive surgery in the treatment of burns, non-healing wounds and pressure sores is to remove the dead tissue and restore the continuity of the skin without delay. Lyophilised, irradiated, human amnion is a temporary biological dressing conveniently available off-the-shelf. It was used in twenty four patients with burns, eight patients with bedsores and six patients with non-healing ulcers mainly on the foot. The total surface areas of burns sustained were from 2% to 40%. The burns ranged from second degree to deep third degree burns. Amnion was not used in patients with infected third degree burns.The amnion provided good biological cover in all the patients. It was easy to handle and apply, and provided pain relief. The duration of healing varied depending on the extent and depth of the wound and the amount of exudate. The superficial bedsores healed with a single application of amnion. Reduced exudate, healthy granulation tissue and enhanced epithelisation were observed following application of amnion.