®

Biological cryopreservation and

cell expansion of autologous fibroblasts

cell

fact

ory

®

Protagonists in cutaneous rejuvenation

The skin is the organ most subject to changes due to ageing and pathological conditions of the body. These changes are mainly due to the loss of collagen, the most important protein among those responsible for skin support and quality.Collagen is produced by fibroblasts, the cells which contribute to creating the dermal network of fibres, typical of a healthy, compact and elastic skin. Physiological ageing involves a significant reduction in the quality and quantity of fibroblasts in the dermis, to the detriment of collagen production. Over the years, the consequences of collagen loss become apparent through a gradual reduction in skin thickness, compactness and elasticity.

Fibroskill is based on the ingections of autologous fibroblasts extracted from a sample of skin from behind the ear. Thanks to fibroskill it is possible to preserve one’s own cells at -196° C interrupting the physiological ageing process. With the cell cultivation processes foreseen in the Fibroskill protocol it is possible to further rejuvenate cryopreserved cells and multiply them to obtain natural skin rejuvenation.

Fibroblasts

Cell FactoryBioscience Institute is a cell factory dedicated to biological cryopreservation and cellular culture for clinical use and scientific research. Bioscience Institute laboratories are engaged in the isolation, analysis, expansion and planned freezing of several types of cells: hematopoietic cord blood stem cells, adipose-derived stem cells, fibroblasts, keratinocytes and melanocytes. Bioscience Institute, in collaboration with prestigious Italian and foreign universities, conducts research work aimed at extending the possible clinical applications of stem cells to several areas of medicine: cardiology, surgery, dentistry, gynaecology and dermatology. Bioscience Institute laboratories include a 220 m² sterile environment (Clean Rooms) equipped with laser particle counters which constantly monitor the safety level in the room and under the laminar flow hoods. It is possible to monitor the sterility level of these rooms and the quality of the operational procedures adopted by the staff from the www.cellfactory.it website which gives access to the environmental safety parameter control monitors and to the cameras inside the labs. Bioscience Institute has adopted the highest quality standard, thus bringing up to excellent levels the operational procedures and sterility level of the laboratories; all its work can be controlled by anyone through a simple internet connection thus guaranteeing the maximum transparency.

®

Stops the mechanisms involved in cellular senescence

Fibroblasts can be stored for decades in biological cryo-containers at a temperature of about -196°C. A large number of studies conducted in the area of regenerative medicine have shown that cryopreserved cells maintain the biological age and characteristics they had at the time they were frozen.The preservation of fibroblasts is a prevention tool which makes possible the use of cells that are always young, even after many years, for anti-ageing and skin lesion treatments. Bioscience Institute cell factory preserves fibroblasts making them available for treatment anytime they may become necessary during the cryopreservation period.

Cryopreservation

Fibroblasts treatments interrupt physiological skin ageing

Cryopreservation interrupts ageing of preserved fibroblasts

The use of autologous cells guarantees absolutely natural results

Treatments may be repeated up to 10 times thanks to cryopreserved cells

The use of the patient’s own fibroblasts prevents any risk of rejection or infection

The effectiveness of fibroblasts clinical application is widely demonstrated in literature

Advantages

Interrupts skin ageing processes

Preserved fibroblasts can be expanded in a few days and reach a concentration of approximately 2.000.000/ml. For each treatment, the laboratory will provide a 3ml vial containing an amount of fibroblasts sufficient for the treatment of large areas of skin.The treatment is done by mean of a microscopic needle which is supplied with the vial.The process is painless and avoids temporary skin marks.

Use of autologous fibroblasts

®

Letteratura scientifica

P A R T N E RISTITUTO NAZIONALE

B I O S T R U T T U R E

B I O S I S T E M I

BUREAU VERITASCertification

GMP

UNI EN ISO 9001:2008

®

800 985 177

StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: results from a prospective, randomized, controlled dose escalation trial. Centanni JM. et al., Ann Surg. 2011 Apr;253(4):672-83.Injection of cultured autologous fibroblasts for human vocal fold scars. Chhetri DK et al., Laryngoscope. 2011 Apr;121(4):785-92. Autologous skin fibroblast and keratinocytes grafts in the treatment of chronic foot ulcers in aging type 2 dyabetic patients. Monami et al., J Am Podiatr Med Assoc., 2011; Feb; 101(1):55-8.Surgical Option for the Correction of Peyronie’s Disease: An Autologous Tissue-Engineered Endothelialized Graft. Imbeault A. et al., J Sex Med. 2011 Jun 30.Acellular dermal matrix seeded with autologous gingival fibroblasts for the treatment of gingival recession: a proof-of-concept study. Jhaveri HM. Et al., J Periodontol. 2010 Apr;81(4):616-25.Improvement of the maxillary bone growth suppression in the cleft palate operation with cultured dermal substitute: animal experiment and patient reports in preliminary clinical application. Kurokawa N. et al.,J Plast Reconstr Aesthet Surg. 2010 Mar;63(3):456-8.Treatment of atrophic cutaneous leishmaniasis scar using autologous fibroblasts and keratinocytes (a case report and literature review). Nilforoushzadeh MA. et al., J Res Med Sci. 2010 Mar;15(2):125-.6.Soft tissue augmentation by autologous cultured fibroblasts transplantation for treatment of wrinkles and scars: a case series of 20 patients. Nilforoushzadeh MA et al., J Res Med Sci. 2010 May;15(3):167-71.Potential of skin fibroblasts for application to anterior cruciate ligament tissue engineering. Tremblay P., et al., Cell Transplant. 2010 Nov 5.A phase IIa open-label dose-escalation pilot study using allogeneic human dermal fibroblasts for nasolabial folds. Lowe NJ. et al., Dermatol Surg. 2010 Oct;36(10):1578-85. Clinical application of autologous three-cellular cultured skin substitutes based on esterified hyaluronic acid scaffold: our experience. Scuderi et al., In Vivo. 2009 Nov-Dec;23(6):991-1003.Myoblast and fibroblast therapy for post-prostatectomy urinary incontinence: 1-year follow up of 63 patients. Mitterberger M. et al., J Urol. 2008 Jan;179(1):226-31. The clinical application of autologous bioengineered skin based on a hyaluronic acid scaffold. Scuderi et al., Biomaterials, 2008 Apr;29(11):1620-9.Preliminary survival studies on autologous cultured skin fibroblasts transplantation by injection. Zhao Y. et al., Cell Transplant. 2008;17(7):775-83.Autologous myoblasts and fibroblasts for female stress incontinence: a 1-year follow-up in 123 patients. Mitterberger M. et al., BJU Int. 2007 Nov;100(5):1081-5.Autologous fibroblasts to treat deep and complicated leg ulcers in diabetic patients. Cavallini M. et al., Wound Repair Regen. 2007 Jan-Feb;15(1):35-8.A randomized, double-blind, placebo-controlled study to determine the safety and efficacy of cultured and expanded autologous fibroblast injections for the treatment of interdental papillary insufficiency associated with the papilla priming procedure. McGuire MK. Et al., J Periodontol. 2007 Jan;78(1):4-17.The use of cultured autologous fibroblasts in burn wounds healing process. Karchilaki I. et al., Burns. 2007 Sep;33(6):791-2.Tissue engineering of the anterior cruciate ligament: a new method using acellularized tendon allografts and autologous fibroblasts. Tischer T. et al., Arch Orthop Trauma Surg. 2007 Nov;127(9):735-41Autologous cultured fibroblast injection for facial contour deformities: a prospective, placebo-controlled, Phase III clinical trial. Weiss RA et al., Dermatol Surg. 2007 Mar;33(3):263-8.Clinical results of an autologous engineered skin. Llames S. et al., Cell Tissue Bank. 2006;7(1):47-53.Lamina propria replacement therapy with cultured autologous fibroblasts for vocal fold scars. Chhetri DK. et al., Otolaryngol Head Neck Surg. 2004 Dec;131(6):864-70.Reconstruction of extensive soft tissue loss by transplantation of dermal and epidermal equivalents. Hollander DA et al., Zentralbl Chir. 2004 Jan;129(1):29-36.Autologous cultured fibroblasts as cellular therapy in plastic surgery. Boss et al., Clin Plast Surg 2000; 27:613-26.Tissue-engineered skin (Apligraf) in the healing of patients with epidermolysis bullosa wounds. Falabella AF. et al., Arch Dermatol. 2000 Oct;136(10):1225-30.Safety of injectable autologous human fibroblasts. Keller G. et al., Bull Exp Biol Med. 2000 Aug;130(8):786-9.Autologous fibroblasts for treatment of facial rhytids and dermal depression: a pilot study. Watson et al., Arch Facial Plast Surg. 1999; 1:165-70. The use of tissue-engineered skin (Apligraf) to treat a newborn with epidermolysis bullosa. Falabella AF. et al., Arch Dermatol. 1999 Oct;135(10):1219-22.Intradermal injection of autologous dermal fibroblasts improves wound healing in irradiated skin. Ferguson PC. et al., J Surg Res. 1999 Aug;85(2):331-8.Autologous human collagen and dermal fibroblasts for soft tissue augmentation. West TB. Et al., Dermatol Surg. 1998 May;24(5):510-2.A cultured skin substitute composed of fibroblasts and keratinocytes with a collagen matrix: preliminary results of clinical trials. Kuroyanagi Y. et al., Ann Plast Surg. 1993 Oct;31(4):340-9. Autologous Fibroblast Transplantation in Facial Deformities (NCT01115634) Use of Biopsy Punch for Skin Biopsies for Fibroblasts Culturing (NCT00340912)Safety and Efficacy Study of Isolagen Therapy in the Treatment of Severe Facial Acne Scarring (NCT00642642)Dermagraft® for the Treatment of Patients With Diabetic Foot Ulcers (NCT01181440)Safety and Efficacy Study of Isolagen Therapy™ in Treatment of Facial Wrinkles and Creases (NCT00654654)Safety and Efficacy Study of Isolagen Therapy™ in the Treatment of Nasolabial Fold Wrinkles (NCT00655356)Safety and Efficacy Study of Isolagen Therapy™ in the Treatment of Nasolabial Fold Wrinkles (NCT00649428)Safety and Efficacy Study of Isolagen Therapy™ in Treatment of Interdental Papillary Insufficiency (NCT00655889)Pivotal Trial of Dermagraft® to Treat Venous Leg Ulcers (NCT00909870)Efficacy and Safety Study of DERMAGEN® vs Conventional Treatment to Treat Diabetic Neuropathic Foot Ulcer (NCT00521937) StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns (NCT01437852)StrataGraft™ Skin Tissue In The Surgical Management Of Complex Skin Defects (NCT00618839)Pivotal Trial of Dermagraft® to Treat Diabetic Foot Ulcers Advanced (NCT01181453)

1.

2.3.4.5.

6.

7.

8.

9.10.11.

12.13.14.15.16.17.

18.19.

20.

21.22.23.24.25.26.27.28.29.30.31.

32.33.34.35.36.34.38.39.40.41.42.43.44.

www.cellfactory.it