WHAT IS ALLOPLANT®?

The Russian Eye and Plastic Surgery Centre's scientific results and their practical realization made it possible to develop the concept of regenerative surgery on the basis of the Alloplant transplantational technologies. Long-term experience of the experimental and clinical studies of the produced Alloplant biomaterials is a convincing proof of their selective effect upon the process of reparative regeneration of different tissues and anatomical structures. This exclusively promising line opens up opportunities for treatment of widely spread autoimmune, hereditary and vascular diseases. When using different types of the Alloplant biomaterials, it is possible to stimulate regeneration of sanguiferous and lymphatic vessels, cornea, sclera, integument, conjunctiva, nerves, parenchyma of liver, mucous coat of gastrointestinal tract, etc. Alloplant has been successfully used for the last two decades in the treatment of diabetic retinopathy, retinitis pigmentosa, optic nerve atrophy, uveitis, thromboses of the retinal veins, leucomas, traumata, keratites, myopia, tumours, burns and congenital defects.

Alloplant is widely used in ophthalmology, maxillofacial surgery, plastic surgery, stomatology, thoracal surgery, neurosurgery, proctology, orthopedics, traumatology, liver surgery, gynecology, etc. We have gained experience of using Alloplant biomaterials in different fields of pediatric surgery. Besides special transplants have been developed for reconstructive surgeries in children in case of maldevelopment of the digestive, respiratory, musculoskeletal systems. All the Centre’s scientific, medical and productional structures are functioning as a unified complex in which the time between the development process of the new technology and its implementation is maximally shortened.

Production control

The Russian Federation Health Ministry approved the wide clinical application of the Alloplant graft biomaterial (Certificate № 901 of 22.07.1987) Alloplant is included into the Russian General Classification of the biological products and allowed for the wide clinical application. Specification №42-2-537-93 (The Russian Federation Health Ministry; Registered № 056/003230 of 17.05.1993).
The harvesting of the donor cadaveric material is performed in accordance with the Russian Federation Law “About the transplantation of organs and tissues” № 4181-1 of 22.11.1992.
Before it goes into production the biomaterial undergoes the compulsory testing for AIDS (HIV), hepatitis B, hepatitis C, and syphilis. Besides these types of tests we use at different stages of the production the following additional types of control:

1.     Morphologic

2.     Biomechanical

3.     Visual and microvisual

4.     Optic polarization

5.     Histochemical

6.     Bacteriological

The developed technologies of the biomaterials processing and preservation and methods of their control guarantee sterility safety of their structure and plastic properties for the period of 5 years. The biomaterials should be stored at room temperature.

What is Alloplant biomaterial? (information for doctors)

It is well known that there are different allotransplantation tissues : donor sclera, tendon, fascia lata, fat, skin, etc. But there also exist some negative moments of tissue allotransplantation, namely: immunological incompatibility of tissues (K.Seifert, 1970; J. Bujia et al., 1991; A. Beigel et al., 1991), rejection (R. Klen, 1962; J. Tauro et al., 1991) and scarring around the allograft (A. Titova et al., 1979; M. Vrabel et al., 1993). This negative moments do not give the opportunity to use the tissue allografts widely in practice. For instance, the reduction of the immunological incompatibility of tissues and prevention of the allograft rejection require the application of various immunosuppressive drugs, which are harmful for the patient and can not give a reliable effect (R. Diasio, A. Lobuglio, 1996). The postoperative scarring following the allotransplantation can cause different complications like the optic nerve compression, formation of the drawn scar on the skin, deformation of the eyelid, etc.

Our preliminary experimental investigations showed that the tissue allotransplantation can not only provoke the immune reaction, but also stimulate the regeneration of the recipient tissues. Unfortunately, it is the regeneration of the scar that is mainly stimulated, but sometimes the regeneration elements of the natural reci pient tissues also take place. In view of this, we supposed that under certain conditions of tissue allotransplantation the growth of the natural tissues may be achieved. We believed that the investigation of this problem is of a paramount interest and importance, since it can open up new possibilities of surgery, connected with human tissues regeneration.

Purpose of research

To reduce the antigenicity and stimulate the replacement of tissue allografts by natural reci pient tissues.

Material of investigations

1.     Different tissues (tendon, fascia, skin, dura, fat, sclera, etc.) from 105 human cadavers

2.     Experimental allografting (rabbits — 176, rats — 60, cats — 16) with postoperative observations at 3, 5, 7, 14, 21, 30, 60, 90, 120, 180 and 360 days

Methods of investigations

·         anatomic

·         histologic

·         histochemical

·         electron microscopy

·         electron histochemical

·         immunologic

·         morphometry and photometry