Table 4 Tissue engineering products approved for marketing by the SFDA
From: Regenerative medicine in China: main progress in different fields
Company | Time | Name | Constitute | Application | Registration No. |
|---|---|---|---|---|---|
Beijing Jieya Laifu Biotechnology | 2006 | J-1 allogeneic acellular dermal matrix | The donation of human body’s skin, removed the host immune rejection of all cells, while keeping intact the original structure with the same extracellular matrix | To repair oral mucosal defects, soft tissue defects. | SFDA (quasi-) word No. 2000 No. 346027, and No. 2006 3460430 |
2010 | AlloDerm | The donation of human body’s skin, removed the host immune rejection of all cells, while keeping intact the original structure with the same extracellular matrix | To repair defect of human dermal | SFDA (quasi-) word No. 2010 No. 3461247 | |
Beijing Qingyuan Albert tissue engineering biological technology | 2007 | Rhino (acellular dermal matrix medical tissue patch) | Acellular dermal matrix derived from donated human skin that undergoes a multi-step proprietary process that removes both the epidermis and the cells that can lead to tissue rejection | To repair various causes of oral mucosa and soft tissue defect. Closing the wound, dental implantation, hernia repair, urethral | SFDA (quasi-) word 2004 No. 3460736 |
Chongqing Zongshen Junhui Biotechnology | 2007 | Artificial skin – gene transfection pigskin | The product performance and composition with fresh skin tissue taken from Bama miniature pig as basic material, and through the introduction of technology and gene transfection of CTLA4Ig gene research. | To repair burns and other trauma wound coverage, to promote wound healing, prevention of microbial infection | The Food Drug Armed (quasi) Word 2007 No. 3461287 |
Qidong Oriental Medicine Research Institute | 2010 | Acellular dermal matrix dressings | Pigskin as raw material, such as viral inactivation process with acellular prepared from a pig dermal extracellular matrix, is a porous three-dimensional network structure; mainly composed of collagen. | To repair superficial II degree burn wounds, donor site wounds, deep cut (cut) scab wound granulation wounds and other wounds. | SFDA (quasi-) word No. 2010 No. 3641111 |
Shaanxi Eyre skin Biological Engineering | 2007 | Tissue engineering skin | A bilayer artificial skin substitute: epidermal layer is composed of human epidermal cells, dermal fibroblasts from human and bovine collagen. | To repair deep II degree burn wound, not more than III degree burn wound 20Â cm2 (diameter less than 5Â cm) | The Food Drug Armed (quasi) Word 2007 No. 3461110 |
BiotechnologyYantai Zhenghai | 2009 | Skin repair film | Cattle skin tissue after treatment prepared by a series of acellular dermal matrix is composed primarily of collagen | To repair various causes dermal wound repair defects. | SFDA (quasi-) No. 2009, No. 3460425 |
2009 | Biofilm | Cattle skin tissue processed through a series of prepared acellular dermal matrix is composed primarily of collagen, collagen retains the unique three-dimensional structure | To repair a variety of causes dura (spinal) membrane defects | SFDA (quasi-) No. 2009, No. 3460602 | |
2009 | Dental film | The leather prepared after a series of acellular dermal matrix, whose main ingredient is collagen, sterilized by radiation, one-time use | To repair various causes shallow intraoral soft tissue defect repair | SFDA (quasi-) No. 2009, No. 3460404 | |
Biological Technology of Guangdong Grandhope | 2007 | General thoracic surgical repair film | Pig tissue membranes crosslinked epoxy chemical reagents and biochemical transformation of materials made of surgical repair | To repair chest wall, bronchial stump, diaphragmatic, visceral capsular defect, etc. | SFDA (quasi-) word No. 2007, No. 3461317 |
2009 | Sterile biological care record film | The pig offal film, by the addition of antigen and a series of biochemical treatment and viral inactivation and made | Skin burn, burn and trauma, skin defects | SFDA (quasi-) No. 2009, No. 3640426 | |
2011 | Biotypes dura (spinal) membrane patch | Pig membranous tissue as raw material, processed into biotechnology, should be finished smooth side, the other side is allowed villous or striped or grid-like native structure | To repair hard brain (spinal) membrane defect | SFDA (quasi-) word 2008 No. 3460637 | |
Beijing Datsing Bio-Tech | 2011 | Allogeneic bone grafts | Cadaveric bone usually obtained from a bone bank | Dental implants, to repair broken bones that have bone loss, and repair broken bone that has not yet healed | Fresh Armed State Drug Administration (prospective) ganxibaoNo.3460627 (2011) |