Human Tissues & Cells
Tissue and cellular products, an adjunct treatment when no other help can be offered to a patient
Thanks to the developments in the biotechnological fields that routine medical applications of cell and tissue products are becoming easier and more effective today. However, processing and manufacturing human tissue and cells are under strict control of regulations set forth by international standards which are enforced by the national autorities to make sure that cellular product are produced at facilities licenced for operatations according to the cGMP standards (Good Manufacturing Practices). Therefore, the rule of thumb is that before using the stem cells for certain health conditions, the physician must be sure that the product is GMP qualified. We make sure that the raw material (tissue or cells) has been subjected to strict laboratory tests before accepting for processing and manufacturing through dedicated quality assurance procedures pertained to the standard methods applicable to every single step in the processing environment and that the final product released by site manager is offered to physicians with temperature-controlled transport bags for clinical applications. We are pleased to provide following products:
Cells
- Stem cells derived from umbilicard cord, adipose tissue or bone marrow
- Fibroblasts,
- Chondrocytes
- Immunotherapy products.
Tissues
- Cornea
- Heart valves, arteriyel conduits, pericard patches,
- Amniotic membrane (for use in ophthalmology, plastic surgery and dermatology),
- Bone chips, cubes, femoral head, tendons, cartilage,
Cellular Products
These are mesenchymal stem cells (MSCs) derived from umbilical cord, adipose tissue or bone marrow. They comprise a rare population of multipotent progenitors capable of supporting hematopoiesis and differentiating into various somatic cells. Due to this ability, as confirmed by the results of either in vitro experiments or in vivo studies, MSCs appear to be an attractive tool in the context of tissue engineering and cell-based therapy.
As opposed to earlier trials, it has been understood that allogeneic MSCs perform similarly if not better than autologous MSCs. Among these umbilical cord-derived MSCs (UC-MSCs) are thus the most preferred MSCs with regard to their applicability in treating clically a variety of diseases such as arthritis, brain injury and cerebrovascular disease, spinal cord injury, diabetes and its complications like diabetic foot, diabetic nephropathy, diabetic wound ulcers, and diabetic retinopathy, cardiac diseases, hepatic diseases, systemic lupus erythematosus etc.
Originates from patient’s own skin samples obtained usually behind the ear. The tissue sample recovered by simple punch biopsy at the clinic is then processed at the manufacturing facility to produce millions of autologous
living fibroblast. It usually takes 3-4 weeks for the cells to grow and reach to the numbers needed to be used at the clinics where the cell suspension formulated in a syringe is then injected directly into the patient’s dermis on the face where contour defects (wrinkles, crow feets, acne scars ets.) are visible. The process of contour repair involves no surgery and virtually zero risk of hypersensitivity reactions. It is believed that these injected cells create an objectively and subjectively measured improvements in facial contour defects lasting at least 12 to 48 months.
Full-thickness defects of articular cartilage in the knee have a poor capacity for repair. They may progress to osteoarthritis and require total knee replacement. Injuries of the knee cartilage leading to osteoarthritis include lesions disrupting both cartilage and subchondral bone (osteochondral lesions) and lesions limited to the cartilage tissue (chondral lesions) both of which are common after trauma, repeated minor trauma, as well as overt injury of the knee bein the cause of osteoarthritis.
For the past 10 years, the use of autologous chondrocyte transplantation (ACT) in patients with deep cartilage defects in the knee has been clinically proven to be effective as compared to the conventional treatment modalities like mosaicplasty, microfracture or drilling.
When the ACT is to be performed some cartilage slices (weight, 300 to 500 mg) are obtained through an arthroscope from a minor load-bearing area on the upper medial femoral condyle of the damaged knee from the patients under general anesthesia. The samples are transported to the manufacturing facility where they are processed and isolated condrocytes are cultured in millions and seeded into collagen matrix to obtain matrix associated condrocyte layer. The product is usually available in 3-4 weeks for transplantation.
Cell-based immunotherapy uses a cell type from the immune system as therapeutic agent. For this purpose, the cells are first removed from the body, then activated or modified, expanded and finally re-infused into the patient. The type of cellular immunotherapy products are various ranging from autologous monocyte-derived mature dendritic cell vaccine,
Cancer is a major burden and apart from chemotherapeutic agents, the development of new therapeutics have been the subject of major scientific investigation. Recently, the development of immunotherapies, which aim to boost or use the immune system, or its constituents, as a tool to fight malignant cells, has provided a major new tool in the arsenal of clinicians and has revolutionized the treatment of many cancers.
Cellular immunotherapies are based on the administration of living cells to patients. For this purpose, the cells are first removed from the body, then activated or modified, expanded and finally re-infused into the patient.
The major forms of cellular immunotherapies which can be made individually available may include, T cell-based, natural killer (NK) cell-based and dendritic cell (DC)-based products. Which type of product required is a decision given only by a medical or HematoOncology doctors.
Tissue products
Cornea, a gift to be graciously appreciated, is used as a transplantable living tissue to replace a damaged or diseased cornea by a donated corneal tissue (the graft). If the entire cornea is needed to be replaced it is known as penetrating keratoplasty while only part of the cornea is replaced it is called as lamellar keratoplasty. The graft is taken from a recently deceased individual with no known diseases or other factors that may affect the chance of survival of the donated tissue or the health of the recipient. Therefore, it must be regarded as a ‘gift’ to those who need sight restoring.
We make sure that corneas are from the certified state-of-the-art laboratories providing the highest-quality tissue and advanced processing methods. We currently have contracts with well-known EBAA accredited tissue banks and will be very pleased to supply corneas according to the needs of your trasplant center.
The introduction of valve replacement surgery in the early 1960s has dramatically improved the outcome of patients with valvular heart disease and estimated number of valve substitutions performed worldwide is more than 400 000 per year.
Among different types including mechanical aortic valves, transcatheter or percutaneous aortic valves we can provide biological aortic valves made of biological tissue that can be xenogenic (bovine or porcine) or allogenic (homograft) as well as vascular conduits for coronary bypass surgery besides the bovine pericardial patch designed for a variety of applications including closure of intracardiac defects, repairing septal defects, annulus repairs, ardiac and vascular reconstruction and repairs etc.
It is the innermost layer of the placenta and consists of a thick basement membrane and can be used as a graft or as a dressing in different surgical subspecialties like ophthalmology, dermatology and plastic surgery. Amniotic membrane is mainly used in pterygium excision, reconstruction of the conjunctiva Surface, limbal stem cell deficiency or persistent epithelial defects, corneal ulcer and ocular surface burns
The process is in progress…