DIZG | German Institute for Cell and Transplants
part of the MTF, the worlds largest bone bank
We represent DIZG on the Nordic market and provide allografts to surgeons for less invasive reconstruction surgery and more bio-logic grafts, than synthetic or Xenografts. By having access to the healing potential from the patient, allografts become a straight forward solution.
In Germany, human cell and tissue transplants are regulated as medicinal products (drugs) and require a manufacturing licence and pharmaceutical approval by the local and a marketing authorization from the competent authority respectively.
The biological safety, all aspects of the manufacturing process and clinical application of the transplants are continually monitored and controlled by the relevant governmental authorities. The transplants are processed in GMP compliant clean room suites. DIZG has 11 manufacturing licenses for human tissue transplants.
Less invasive way to do transplants and paired with the healing potential from the patient its the safe choice
ALLOGRAFTS | The portfolio
ALLOGRAFTS | BONE CHIPS and CYLINDERS
From cancellous bone chips in many sizes to blocks and bone segments. E.g. malpositioned drill tunnels must often be filled in revision cruciate ligament surgery. Allogenic bone transplants are ideal in these cases as a new, stable boney substrate is formed over a period of about four to six months and a new tunnel can be drilled. The transplants are available as Spongiosa, crushed, Spierings chips (a mixture of cancellous and cortical bone, various pack sizes and grains) and as Spongiosa cylinder.
ALLOGRAFTS | Epiflex
DIZG epiflex® is produced from donated human dermis. The collagen structure is largely preserved due to the tissue-conserving manufacturing process. epiflex® is cell-free. No immune reactions have been observed. epiflex® serves as a scaffold for revascularisation and cell colonisation.
epiflex® is used in a variety of areas from wound coverage, hernia repair and breast surgery, to Rotator cuff repair and Acromioclavicular joint stabilisation
ALLOGRAFTS | TENDONS
Use of an allogenic tendon can be the means of choice in case of repeated injury or if an autologous tendon cannot or should not be removed. Allogenic tendons are also suitable as replacements for injured ligaments. Transplants available are Semitendinosus tendons, Gracilis,Tibialis tendon, anterior, Tibialis tendon, posterior and Peroneus longus tendon. Available as aseptic and avitale.
ALLOGRAFT | DBM Putty
DBM pastös consists of demineralised bone matrix (DBM) gained from human donors, and a biocompatible carrier substance. During the production process, the mineral components are first removed from cortical bone. The thus gained demineralised bone matrix is then mixed with a biocompatible substance, a sodium hyaluronate solution. The putty is fully converted into new bone after approximately six to twelve months following treatment.
Cancellous bone chips moldable
DIZG | German Institute for Cell and Transplants
DIZG | What is tissue donation?
About 25 years ago, when transplantation surgery was still in its infancy, many people began to ask themselves whether they should consider becoming organ donors. By now, most people regard organ donation very positively and many individuals, although still not yet enough, are in support of organ donation. The public debate in the media and the churches, as well as within the family has made decisive contributions to the progress of organ donation. The same is now being said for tissue donation: Too many people are simply unaware of its benefits. Whoever decides to actually look into the subject of tissue donation will end up having a number of pressing questions. It is precisely these questions that we want to help you answer.
DIZG | Application for allografts
TISSUE GRAFTS REDUCE PAIN, RECONSTITUTE THE QUALITY OF LIFE OF PATIENTS AND IMPROVE THE SURVIVAL PROGNOSIS.
The use of human bone grafts will help to replace accident- or operation-related bone loss, to effect a faster cure or to avoid cancer as well as amputations. Tissue transplants would contribute to a significant improvement in the quality of life and social reintegration and ability to work faster. In many cases allografts can help to avoid additional surgery to remove bone from the patient and prevent complications resulting from the donor site.
Tendon grafts, such as the knee allow patients to return to an active life and prevent the artificial stiffening of the joint. In many cases, transmission of the corneas of the eyes, the patients receive vision and prevent blindness. For large-scale burns, associated with high mortality, life can be saved through skin donation. Chronic wounds (e.g. leg ulcers), tumor-related soft tissue loss and hernias can be treated successfully with special skin transplants.
Furthermore a rarer, but important example is the use of the connective tissue covering the front thigh muscle (fascia lata) for immediate surgical closure of congenital defects of the abdominal wall (Gastrochisis) in newborns.
DIZG | Preservation Methods
Freeze drying (GT)The transplants designated with a GT catalogue number are freeze-dried. (Exception: Amnion transplants are dried.) Freeze-dried transplants are stable for 5 years from the date of manufacture, when stored in unopened packaging at, or below 25°C. Human Amnion, dried and DBM, putty, freeze-dried are ready for immediate use without rehydration. All other freeze-dried transplants must be rehydrated in a suitable physiological medium (e.g. isotonic saline) for at least 30 minutes.
Freezing (TK)All transplants designated with a TK catalogue number are frozen. These transplants are stable for 2 years from the date of manufacture providing they are stored unopened in their packaging, at, or below -40°C. Prior to application, frozen transplants should be thawed in a suitable physiological medium (e. g. isotonic saline).
DIZG | Safety
In Germany, human cell and tissue transplants are regulated as medicinal products (drugs), and require a manufacturing license and pharmaceutical approval by the local and a marketing authorization from the competent authority respectively. The biological safety, all aspects of the manufacturing process and clinical application of the transplants are continually monitored and controlled by the relevant governmental authorities. DIZG has 11 manufacturing licenses for human tissue transplants.
Our biological safety system includes
- An extensive donor screening framework
- A comprehensive serological testing scheme that exceeds the standards set by the EU-Directives 23/2004 and 2006/17 and includes 4 Virus PCR tests
- A validated process for the deactivation and removal of viruses, bacteria and fungi
- In-process controls and testing of finished transplants
SEROLOGISCHES SCREENING IM DETAIL:
Serological screening test in detail:HBsAg*, Anti-HBc*, Anti-HCV*, Anti-HIV 1/2*, HBV-NAT, HCV-NAT, HIV-NAT, HAV-NAT, TPHA*, Anti-CMV, Anti-HTLV I/II (** screening tests required by the EU Directive 17/2006 EC