Bioscience Institute, an Italian S.p.A. (Joint Stock Company), was founded in 2006 with fully-paid capital of € 875,000.00. The company owns and has an exclusive management of laboratories where its work is conducted. Since the first year of operation Bioscience Institute has certified all annual financial statements, as required by statute, by the auditors from:
Bioscience Institute has direct relationships with its customers and does not outsource its services to other companies. Moreover the company does not collaborate with commercial companies or intermediaries.
The Policy of Bioscience Institute provides special attention to the guarantees that are offered to the customers. In this regard the company has formed an important social capital and has transferred all the real estate and securities investments as a real guarantee of its activities carried out towards customers. Transparency in the business and administration management is also expressed by the annual voluntarily submission of the financial statements certification.
Bioscience Institute is a CELL FACTORY dedicated to biological cryopreservation, the cell culture and scientific research.
Considering the high value of the stored cells and in compliance with European Directives transposed in Italy, Bioscience Institute operates according to GMP guidelines (Good Manufacturing Practice).
The laboratories are equipped with 220 m² of clean rooms, equipped with the laser particle counter that monitor continuously the level of biosafety. The level of sterility of environments, such as operating procedures, can be monitored on the website www.bioinst.com, in confirmation to the high-level of reliability and safety of laboratories.
Bioscience Institute’s 920 sqm facilities include:
220 m² Laboratory hoods to Class B and Class A
150 m² Laboratories N/C
180 m² Technical rooms
150 m² Administration and Training area
120 m² Caveau cryopreservation
100 m² Logistics area
The Clean Room is a sterile environment where operations that require the guarantee of the highest degree of safety and microbiological quality of the product are performed. To maintain and ensure the highest standard of safety during all operations it is necessary to monitor constantly airborne particles and to control parameters of temperature, humidity, ventilation and pressure.
The laser particle counter
The laser particle counters is certified instrument that analyzes the air in the laboratory by measuring the concentration of particles present.
A system of acoustic and visual alarm warns you about an excessive number of particles. To ensure the maximum sterility of operations, each classified laboratory is equipped with these devices.
The highest quality standards correspond to the maximum biological safety
GMP (Good Manufacturing Practice) is the highest expression of existing quality standards for laboratories, that, such as the Bioscience Institute, conduct research and cryopreservation of stem cells. The minimum requirements laid down by Community legislation in order to carry out the cryopreservation of stem cells, usually adopted by biobanks carrying on this business, do not correspond to the maximum guarantee of biosafety. This guarantee, in fact, is only obtainable through laboratories that operate according to the guidelines laid down by much more restrictive GMP procedures.
These requirements concern not only the planning and construction of buildings and plant construction, but also the operating procedures, applicable only in case if the laboratory has been constructed, equipped and furnished according to this rigid standard.
The stem cells transplantation is a very delicate and risky operation that is conducted in specialized centers. A transplant of stem cells not properly preserved may compromise the patient's life. For this reason there are quality standards that ensure the proper handling of cells in sterile environments, in particular if intended to be used on humans. In Europe, before a transplant, appointed Centers verify the origin of the biological material to be transplanted.
If the laboratory from which the cells has arrived does not have an internationally recognized standard of quality, stem cells cannot be transplanted because they are lacking the necessary guarantees of biosecurity and traceability.
Only strict conservation procedures keep cells usable
The company that offers the service of cord blood cryopreservation must ensure the usability of stem cells in the case of transplant. The high standards of quality and biological safety that must be offered laboratories must also match with appropriate storage procedures, as required by strict protocols GMP (Good Manufacturing Practice). Stem cells stored in different way (not according to GMP procedures) may not be used for possible transplants.
For example, the preservation of the stem cells of the same sample in two separate cavity is considered by international certification bodies as a lack of the basic guarantees of quality. This procedure, that does not comply with GMP protocols, increases by 100% the risk of contamination and compromises the quality and viability of the preserved biological material.
The double storage can be a communication topic of a great emotional impact but absolutely inappropriate from a scientific point of view, so as to represent a negative aspect to be considered in the evaluation of placental blood banks that adopt such procedures.
In this regard, on-site of Osidea NGO, it says: "We must also point out that those strange promoted formulas, where the unit is more or less divided into two or more parts, it is not scientifically correct for possible transplantation for therapeutic purposes. To proceed with a transplant there is a need of high number of stem cells. There is absolutely no sense to allocate 80% to heterologous donation and 20% to autologous conservation, in fact, the remaining 20% is not enough for a transplant. "
In addition to the cryopreservation of cord blood stem cells, Bioscience Institute operates in the promotion and support of projects in clinical and preclinical research.
The main objective of this research is the discovery of new, safe and effective therapeutic applications for cell therapy products that the cell-factory is able to offer. For this reason Bioscience Institute collaborates with research groups of prestigious Italian universities and doctors of international repute.
► PRE-CLINICAL RESEARCH PROJECTS
- Determination of the effects of increasing platelet gel concentrations on the proliferation and differentiation of different cell populations. Platelet gel is a blood product with non trasfusional use containing several Platelet Derived Growth Factors that spread from the gel and support tissue repair. The therapeutic potential of platelet gel has been widely proved both in vitro and in vivo but there is a lack of conformity regarding the data reported in literature. This is probably due to the fact that platelet gel is used as a supplement to normal culture media, without considering the initial concentration of platelets/ul. We are therefore evaluating what are the optimal platelet gel concentrations able to induce the proliferation and/or differentiation of different cell populations: fibroblasts, keratinocytes and Adipose-Derived Stem Cells.
ONGOING - University of Bologna
- Optimization of Adipose Derived Stem Cells isolation techniques. It has been shown how a good isolation rate and expansion ability of Adipose Derived Stem Cells in culture depends both on the technique used to collect the fat and the technique used to isolate the stem cells. In order to standardize and improve the quality and the ADSC isolation rate, we are evaluating different protocols that foresee the mechanical homogenization or the enzymatic digestion as first step to isolate the cells from the fat.
- Evaluation of adult Adipose Derived Stem Cells multipotency and their ability to differentiate into cardiomyocytes or pericytes. ADSC can be widely used for different clinical applications in regenerative medicine as they are easily isolated from the fat, they can be collected from the patient himself, they have a good proliferative ability in vitro, they have low immunogenicity, they are able to integrate into the receiving tissue and interact with the surrounding tissues through paracrine mechanisms. Different studies have also shown that ADSC are able to differentiate into cell populations of the mesenchymal line (adipocytes, osteocytes, chondrocytes, smooth and skeletal muscle cells, heart muscle cells) but also into vascular endothelial cells, neurons, hepatocytes, pancreatic cells and hematopoietic cells. Thanks to their pluripotency, ADSC are frequently used to repair damaged tissues. The purpose of this project is to to evaluate the effects of the treatment with ADSC with physical stimulus combined to a cocktail of synthetic molecules able to increase the efficiency and reproducibility of their differentiation into cardiomyocytes or pericytes.
ONGOING - University of Milan Bicocca
- Analysis of the mechanisms responsible for vitiligo. Vitiligo is a chronic condition that causes a loss of skin pigmentation, caused by an alteration into the amount and functionality of the melanocytes. The causes of this disorders are still unclear, there are different hypothesis: genetic, autoimmune, biochemical, and neuronal. It’s been shown how melanocytes took from non affected areas of the patients are more sensitive to oxidative stress, which is thus a possible marker for this disease. In order to prove this hypothesis, in vitro experiments on melanocytes isolated from healthy and vitiligo patients are being performed.
ONGOING - Istituto Dermatologico San Gallicano Rome
- Evaluation of the secretory activity of Adipose Derived Stem Cells. Adipose tissue actively participates to the endocrine secretion through cytokines and growth factors secretion. Adipose Derived Stem Cells too are able to release growth factors and cytokines with angiogenetic and anti apoptotic properties. The purpose of this project is to analyze the molecules contained into the secretome released into the culture medium durig ADSC proliferation. ADSC are often used inside biodegradable scaffolds. The analysis of the secretome is also performed after the cells are seeded into a regular meshed polylactic scaffold to highlight possible variations and validate the scaffold system.
ONGOING - University of Bologna
- Development of new scaffolds for tissue engineering applications. Any material used as a scaffold,has to be biocompatible, biodegradable, elastic and resistant.Silk fibroin has been used to realize bioresorbable skin substitutes made by a layer of fibroin and adult stem cells isolated from adipose tissue. Those layers showed good results for the obtention of engineered skin (Chlapanidas et al., AICC, 2010).
- Use of adult Adipose Derived Stem Cells for the inversion and or blocking of miniaturization process. The follicle can be considered as a mini organ characterized by growth cycles and loss of hair, that regrows thanks to the synergic activity of its pool of stem cells. Miniaturization is a degenerative process that progressively brings to the development of very short and thin hair with a reduction of the anagen phase and epithelial and mesenchymal compartments dimensions. It’s been recently discovered that ADSC are able to induce hair growth of immunosuppressed animals in vitro and in vivo. In this case, stem cells isolated from adipose tissue are tested for their ability to induce hair regeneration
- Research of new active molecules for tissue regeneration in case of myocardial infarction. Hyaluronan mixed esters of butyric and retinoic acid (HBR) are able to induce cardiogenesis and vasculogenesis either in vitro in mesenchymal cells isolated from the dental pulp, spinal cord and placenta or in vivo, in infracted rats. Mesenchymal stem cells transplantation derived from the placenta and treated with HBR increase capillary density in heart, normalizes ventricular functionality and reduces scar tissue. From a molecular point of view, HBR induces the expression of Smad proteins that play a key-role into cardiogenesis processes. Successive studies showed how the injection of HBR into infracted rat hearts afforded substantial cardiovascular repair and recover of myocardial performance thanks to the recruitment of Stro-1 stem cells into a pro-angiogenic paracrine circuitry of angiogenetic factors. These findings may pave new perspectives in clinical studies for myocardial regeneration, without the need of stem cell transplantation. (Ventura et al. JBC 2007; / Lionetti et al., JBC 2010; / Maioli et al., PlosONE 2010).
► CLINICAL RESEARCH PROJECTS
- Autologous adipose-derived stem cells for treatment of sistemic sclerosis. Systemic sclerosis is a rare heterogeneous disease, characterized by progressive accumulation of fibrotic tissue on skin and internal organs. Autologous adipose-derived stem cells (ADSC) were expanded in vitro and administered to 6 patients with systemic sclerosis. ADSC were injected as a suspension in a solution containing hyaluronic acid. This treatment determined a significant improvement in tightening of the skin without complications, suggesting that ADSC are a potentially valuable source of cells for skin therapy (Scuderi et al., Cell Transplantation, in press).
- Autologous adipose-derived stem cells for the regeneration of cutaneous tissue. Thanks to their pluripotency, adipose-derived stem cells (ADSC) are one of the most promising populations of mesenchimal stem cells for regenerative medicine applications. Autologous, in-vitro expanded ADSC are administered to patients with severe cutaneous defects, such as burns, or aesthetic alterations, as stretch marks or cutaneous laxities. After treatment, morphological and functional analysis are performed to evaluate cutaneous regeneration.
ONGOING - University of Bologna
- Autologous in-vitro expanded keratinocytes for reconstruction of oral mucosa.. Keratinocytes isolated from an oral mucosa biopsy are isolated and expanded in vitro till the formation of an epithelial patch. Patches are then applied to areas of the mouth where keratinized tissue is absent or incomplete.
ONGOING - University of Milan
- Autologous in vitro-expanded keratinocytes for vaginal reconstruction in patients with Mayer-von Rokitansky-Kuster-Hauser syndrome.. Mayer-von Rokitansky-Kuster-Hauser syndrome is characterized by vaginal agenesis. A 28 years old woman with this syndrome underwent a successful autologous vaginal tissue transplantation. The transplanted patch was composed by in vitro-expanded keratinocytes obtained from a full-thickness mucosal biopsy from the vaginal vestibule (Benedetti Panici et al., Human Reproduction 2007)(Benedetti Panici et al., Human Reproduction 2007).