The Patient’s Platelet Rich Plasma ... - mte-eichholz.com · A-PRP: the patient’splatelet concentrate prepared with Cellular Matrix provides an autologous reservoir of growth

The Patient’s Platelet Rich Plasma combined with Hyaluronic Acid for Skin and Mucosa Regeneration

CMSK-06.12.2016-V2-© Regen Lab SA

A-PRP: the patient’s platelet concentrate prepared with Cellular Matrix

provides an autologous reservoir of growth factors from the patient’s blood.

Platelets are key factors in hard and soft tissue repair mechanisms. They provide essential growth factors, such as FGF, PDGF, TGF-ß, EGF, VEGF, which are involved in stem cell migration, differentiation and proliferation. They also stimulate fibroblasts and endothelial cells to induce, respectively, new extracellular matrix deposition and neo-vascularisation. Platelets are concentrated from the patient’s own blood.

Plasma contains many factors essential for cell survival including nutrients, vitamins, hormones, electrolytes, growth factors such as IGF and HGF, and proteins. Among the plasma proteins, there are vital molecules for the coagulation process and generation of the fibrinpolymer that will serve as a scaffold for cell migration and new tissue generation.

A revolutionary innovation for skin and mucosa care combining two treatment concepts in one for optimal results.



In soft tissues PRP was shown to 1,2 :

- Increase the production of collagen- Enhance skin elasticity, tone and thickness- Stimulate stem cell differentiation and proliferation- Trigger angiogenesis- Create a volumising effect.

Hyaluronic Acid (HA) is a high molecular weight glycosaminoglycan (GAG) widely distributed throughout connective and epithelial tissues.

Thanks to its unique capacity to retain water up to 1000 times its weight, HA is the ideal substance to alleviatevaginal dryness without irritating the mucosa:

- Major component of the extracellular matrix with important roles in cellular proliferation and migration- Facilitates migration and proliferation of epithelial cells 3

- Induces de novo collagen synthesis in human skin in vivo 4

- Natural 3-dimensional mesh that increases in time the biological effect of PRP.


Immediate formation, in one easy step, of a cell-friendly HA network in which platelets are dispersed, using a system which is specifically approved for the preparation of the PRP/HA association.

In order to guarantee sterility, all Cellular Matrix Kits preparations are carried out in a One Step Closed System.

CellularMatrix is prepared with a Medical Device manufactured by Regen Lab and certified CE0499.


SAFETY


Product Characteristics

• Fast and simple process

• Cellular Matrix is a class III Medical Device containing 2 ml of a natural, non-crosslinked HA at a concentration of 20 mg / ml (40 mg total), in addition to the thixotropic cell-separation gel and the sodium citrate anticoagulant solution.

• Treatment regimen of up to 3 intra dermal/intra mucosal injections

• 3 standard Regen pharmaceutical grade glass tubes packaged in double blister, sealed with 2FS Tyvek® in accordance with ISO 11607

• Both patient’s PRP and HA contained in Cellular Matrix have excellent safety profiles in clinical practice.



One Step Procedure / Closed System



Instructions for Use




GSM refers to a collection of symptoms and signs associatedwith a decrease in estrogen 5 :

Genitalsymptoms

DrynessBurningIrritation

Sexualsymptoms

Lack of lubricationDiscomfort/pain

Impaired function

Urinarysymptoms

UrgencyDysuria

Recurrent urinaryinfections



Physicians must always verify that the written practices described are in accordance with local laws.

TREATMENT OF GENITOURINARY SYNDROME OF MENOPAUSE (GSM)

Thanks to the synergistic effects of PRP and HA, Cellular Matrix represents a non-surgical treatment option to manage these commonpostmenopausal symptoms and provides patients with addedbenefit and comfort through:

- New vascularisation stimulated by vascular endothelial growth factor (VEGF) release.- Increased elasticity thanks to new synthesis of collagen and elastin.- Overall decrease in pain and discomfort.



RESTORATION OF SEXUAL PLEASURE

Cellular Matrix gives women a chance to make them feel better withtheir intimacy, restoring sexual pleasure.

Sexual pleasure can be lost because of aging, psychosocial factors or vulvovaginal damages followingpregnancy and childbirth.

They are frequent sources of female sexual dysfunction leading to a variety of symptoms such as 6,7 :

Lack of lubricationPain

Reduced desire and arousal Inability or difficulty to reach orgasm



Cellular Matrix is also evaluated for lichen sclerosus, bartholinitis, post C-section scars, episiotomy scars, stretch marks treatments.



O-Shot

1 x Cellular Matrix tube

1ml injected directly into clitoris with 27G needle

2-3ml injected suburetheraly with 23-27G needle

Two injections three months apart

Follow up treatment every 12-18 months

Always aspirate prior to injecting



Stress Urinary Incontinence

• 1 x Cellular Matrix tube

• Injection performed suburetheraly with 23-27G needle

• Three injections one month apart

• Follow up treatment every 12-18 months

• Always aspirate prior to injecting



Dry Vagina

• 1 x Cellular Matrix tube and 1x BCT tube

• Inject Cellular Matrix in introital part with 27 gauge needles

• Inject BCT in the whole vagina with needle adapter and 23-27G needles.

• Three treatments 3-5 weeks apart

• Follow up treatment every 12-18 months




Lichen Sclerosus

• 1-2 Cellular Matrix tubes

• Injectable volume depends upon size of treatable area

• 27G needle

• Three treatments 2-5 weeks apart



REFERENCES


1. Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg 2004;62:489-96.

2. Cho JM, Lee YH, Baek RM, Lee SW. Effect of platelet-rich plasma on ultraviolet b-induced skin wrinkles in nude mice. J Plast Reconstr Aesthet Surg 2011;64:e31-9.

3. Laurent TC, Fraser JR. Hyaluronan. FASEB J 1992;6:2397-404.

4. Wang F, Garza LA, Kang S, et al. In vivo stimulation of de novo collagen production caused by cross-linked hyaluronic acid dermal filler injections in photodamagedhuman skin. Arch Dermatol 2007;143:155-63.

5. Portman DJ, Gass ML, Vulvovaginal Atrophy Terminology Consensus Conference P. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophyfrom the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause 2014;21:1063-8.

6. Laumann EO, Nicolosi A, Glasser DB, et al. Sexual problems among women and men aged 40-80 y: prevalence and correlates identified in the Global Study of SexualAttitudes and Behaviors. International journal of impotence research 2005;17:39-57.

7. Basson R, Leiblum S, Brotto L, et al. Definitions of women’s sexual dysfunction reconsidered: advocating expansion and revision. Journal of psychosomatic obstetrics and gynaecology 2003;24:221-9.



Intellectual Property Rights (IPRs) as Core Assetswww.regenlab.com/patents

The Cellular Matrix product is also known as REGENMATRIX®, which isa registered trademark of Regen Lab SA in Europe, United States and

other countries

- WO2011/110948, WO2013/061309, WO2016/083549, U.S. patent US8945537, Canadian Patent CA2789533C, Chinese Patent

ZL2011800215953, Australian Patent AU2011225828B and Patents Pending including EP2544697, US2015125436, JP2013522186,

IL221133, RU2012143493, KR20130067247, 7167/DELNP/2012, HKA.13104932.8, US2015151858 and EP2771241


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The Patient’s Platelet Rich Plasma ... - mte-eichholz.com · A-PRP: the patient’splatelet concentrate prepared with Cellular Matrix provides an autologous reservoir of growth