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NEEDLE-ROLLERS AND TOPICAL-PRP POSE SUBTLE HEALTH-RISKS TO AESTHETIC  SALONS UNDER CERTIAN CONDITIONS.

PLATELET-RICH FACIAL REJUVENATION (PRP): Pro’s and con’s

PRP facial rejuvenation in a male client.What does this mean? This briefly means that the skin of the aging-face can be “rejuvenated” by multiple tiny hypodermic needle-injections of an extract of your blood-plasma. Doctor takes a blood-sample from your arm, prepares the plasma and then re-injects it under the skin of your face to initiate a rejuvenation process, hopefully to improve the integrity of the face and to reduce fine-lines and wrinkles. Visible results are seen after 2 months and are subtle. More specifically, the forehead, peri-orbitally (for eye-bags, lines and crow-feet), naso-labial regions, sides of the cheeks, above and below the lips and the neck are targeted: the back of the hands as well). In cigarette smokers, PRP has no effects at all. About 8-10 cc of plasma is used. It is a form of biological or natural rejuvenation of the face without immediate need for RF, IPL and laser. But PRP definitely does not replace Botox® and fillers such as Restylane® or Juvederm®. Persons with severe solar damage also respond poorly to PRP.

PRP cannot do the following. The results are variable at best and do not achieve the rejuvenation outcomes of a face lift or mini-face lift. Rejuvenation criteria and outcome is graded as modest. PRP really cannot improve sagging, jowls, bags under the eyes, remove ugly wrinkles or remove hyper-pigmentation and brown-blotches. The conventional products and devices, like Botox®, fillers, IPL and laser are still needed. PRP is insufficient as stand-alone therapy and soon wears off and needs re-doing. Or another device has to be added to control the wrinkles that came back after PRP. PRP offers no volumetric advantages and is light-years behind fillers such as Juvederm® or Restylane® (hyaluronic acid). Local research has shown that PRP makes no measurable scientific impact on stretch marks and acne scarring.

Hyaluronic natural skin fillerPRP is not cost effective as proclaimed (a fallacy) and is more expensive than BOTOX®, JUVEDERM® or RESTYLANE®. Rather save up for BOTOX® or filler such as Juvederm® or Restylane®.

PRP is not the general panacea for facial rejuvenation without surgery and for the induction of a youthful face and beauty. It is just another cosmetic alternative, behind Botox® and fillers and has the drawback in the salon that blood and needles are needed for the process. The concept puts people off. Sometimes the face after PRP is quite swollen, looks gross, and needs at least 3-days down time. Feed-back from cosmetic clients show that PRP is not as popular as promotions make out. Frown-lines cannot be effectively treated as with Botox® and jowls do not disappear. A lot of these ladies feel queasy when they hear that blood and needles are needed. They rather prefer the needle prick for Botox® or filler, because they know they are going to get a definitive result.

PRP still needs convincing evidence, such as with Botox® and Fillers, that the biological route with blood-plasma is the preferred aesthetic choice. For the foreseeable future, because of unpredictable outcomes, biologicals such as PRP will not replace Botox® or Fillers.

PRP is not a filler, and stem-cells are not injected.

LED, RF, IPL, fractional laser, with Botox® and fillers, remain central to facial rejuvenation and maintenance of a youthful face. These may still have to be used later, because the PRP does not always work. Both PRP and fillers do not last for ever and the client still has to go back to the salon for maintenance facial rejuvenation. One must maintain perspective. So when you look in the mirror the wrinkles and fine lines may still be there if the PRP fails to do the job. And this can happen to you. Do not have high expectations, although the treatment is fairly popular in the East. Results can be marginally improved by rolling the PRP into the skin with a needle roller if the client dislikes injectionsBut you cannot have IPL, RF, laser, Botox, and PRP at one sitting. You run risks. Not every-body’s cup of tea if you are used to RF, IPL or laser and PRP needs to be done by an experienced person that knows what is going on. In South-Africa there are various products available under the following brand-names: Regen®, Plateltex®, MyCells®. The procedure is generally safe, but there are hidden risks and disappointments and we need to talk about them and should be brought to your attention if you wish to undergo “PRP” treatment. Out there are a lot of phonies.

Skin needle-roller device for facial rejuvenation.Rollers: The aesthetic world is very competitive and there are voices that suggest that roller-rejuvenation gives a better and faster result than with fractional-laser at a fraction of the price. The introduction of rollers embedded with needles and simultaneous use with PRP (platelet-rich plasma) for facial skin rejuvenation pose subtle health-risks for that salon, staff and clientele due to the danger of transmission of harmful and potentionally lethal viruses ( from contaminated secretions) to unknowing, innocent and naive clients. There are rules to be followed and health-security precautions taken. Read on. The health-risks of RF, IPL, Laser, botulinum, peels, mesotherapy and fillers and micro-dermabrasion are minimal in the hands of a plastic-surgeon or dermatologist skilled-in-the-art. Most clients used to these conventional modalities, seldom convert to PRP. So, if using biologicals, such as a needle-roller individually or in combination with PRP for beauty/rejuvenation treatment, are there any risks and what preventative action have you taken to prevent cross-infection of AIDS or hepatitis in the salon that can affect other clients? Don’t forget, you are using human blood-component therapy to inject into the face.

“SKIN-PRICKING” REJUVENATION-ROLLERS AND TOPICAL-PRP BLOOD PLASMA-GEL RED-FLAGGED FOR POTENTIAL TRANSMISSION OF HUMAN VIRUSES: practise safety protocol needed.

An intentional blood-transfusion in a hospital is a closed-system. Using PRP topically on the skin is an open-system with possibility and potential to spread disease by contamination or cross infection, if that patient is a carrier of disease such as hepatitis. The purpose of the skin-rollers and needle is to prick and puncture the skin and make small tiny bleeding holes through the skin on the sides of the cheek and neck (there are various sizes and length of needles to penetrate through the epidermis into the dermis) which heal, form new collagen and rejuvenate the skin. The healing of the bleeding prick-wounds with crusting is supposedly directed at enhancing facial-rejuvenation in the pricked areas, augmenting the skin-texture and reducing wrinkles and lines. Healing can be further advanced by the topical-application or intra-dermal injection of platelet-rich plasma (PRP), much the same as in the application of mesotherapy. Or the PRP can be rolled into the skin by the use of the needle-roller. The motivation is that the PRP provides extra healing growth-factors (GF) that possibly could stimulate mesenchymal-cells and skin-rejuvenation. The danger is that the whole skin area is covered with a thin invisible layer of blood and potentially contaminated with HIV-AIDS virus, hepatitis B and C virus, especially if the client is serology positive. Exposure of the public to contaminated blood-products is a bad thing and against health regulations. And your clinic is not in a controlled hospital area under jurisdiction. Using PRP in an operating theatre is no problem.

After passage of the needle-roller.Risk of cross-infection with un-hygenic practice. One is not just blood-letting, but one is processing the blood-plasma and re-injecting it under the skin. Contamination of the product can occur in any one of these steps (and made worse by an accidental or inadvertent needle prick with contaminated tip). As a salon or clinic owner you do not know if the clients frequenting your salon practise safe-sex, have or potentially are at risk for HIV-AIDS and hepatitis B and C. These risk-clients may well carry these deadly viruses in the blood. They will not disclose their blood-status to the salon owner (or have to) and this risk has to be taken into account to protect other public and innocent clients that come to your salon or rooms. The detection of one client’s virus DNA in another and supposedly contracted in your salon, because of lax hygiene-practice, means prosecution. Many questions are asked with the use of blood-component treatment (like PRP) outside of the controlled hospital environment. When you prick the face with a rejuvenation-needle-roller, blood runs and seeps out all the punctures and contaminates the area. See the illustration. This is micro-blood-letting which allows oozing of blood-components. Some needles are longer than others, and one must select the correct size to allow for the thickness of the dermis. This can vary considerably from client to client and not every face is the same. The contaminated areas are invisible to you. When the blood is wiped, the dressings, room, bed, pillow, sheet, working-surfaces and dirt-bin potentially harbour the deadly viruses if the client is virus-positive. Have you taken precautions to regulate this problem, reduce risk and induce security to your other patients?  These are infectious viral-agents and transmission to unknowing, innocent clients is possible by direct-inoculation (or cross-infection) if the donor blood was virus-positive. These risks do not exist with IPL, RF or lasers.

Regenlab PRP Kit.So, for the use of a roller and needles and where patient blood contamination of the surrounding areas, is possible, a special health-care protocol must be instituted in that treatment room that prevents transmission of dangerous viruses to other clients by contamination. This is a red-flag. Because, disease can be spread by contaminated blood. Self-regulation within administration is needed, or the owner could end up being regulated by the authorities if a health-risk is uncovered or someone contracts hepatitis at your rooms (because a blood-product was used). Trained-nursing personnel should be available to help with sharps and potentially blood-contaminated dressings and drapes. The chances of contracting HIV-AIDS just from skin-contact is zero, but it is a different matter if a client comes into direct contact with such a persons body or fluid-secretions, especially blood or plasma.
Placement of autologous-PRP (derived from donor venous-blood) on the rolled and punctured surface is also a described biological-method to induce facial skin-rejuvenation. The PRP is rolled into the skin and some is presumably absorbed. The PRP does not run into the tiny skin pricks. Normally activated-PRP is injected intra-dermal, to induce rejuvenation, but can be applied as a mask. This does pose contamination hazards to the room again, if the patient is HIV-AIDS positive or a carrier of hepatitis B or C.

So if one wants to use a roller, needles and PRP-gel then one must have a health-care protocol to prevent contamination or cross-infection of staff and other clients (an Enviromental Plan must be in place if the owner of the practice is using infected blood plasma on site). This means use of aseptic-technique, disposable-drapes, careful disposal of contamination material consisting of dressings, sharps, blood collection-tubes, needles and syringes. Rollers can be re-used in the same client, but need autoclaving. Exposure of the skin to blood from persons with AIDS, must be strictly controlled. In some units a skin-roller and Platelet-Rich Plasma would not be considered for skin-rejuvenation in persons with HIV-AIDS or underlying hepatitis B and C, because of the environmental hazards and risks of bodily fluids, especially in the treatment-room of the salon. Supervision by a medically qualified person is advisable. Staffs need to wear protective clothing, eye-wear, gloves, avoid needle-pricks, and masks. SOP should be in place for the treatment room, especially where biological, and blood-component therapy, are in use.

Dangers of client exposure to the secretions of previous clients with HIV-AIDS and hepatitis B &C (blood, plasma, plasma gels, PRP-gels) include transmission of disease. All surfaces must be disinfected regularly and all sharps and contaminated swabs carefully disposed of within SOP.

SMART CLOT AND ACTIVATED-PRP NEEDED FOR CELL REGENERATION AND ENHANCEMENT OF HEALING: AESTHETICS AND THERAPEUTICS: NOT UN-ACTIVATED PRP.

PRP cellular maskTransfer of activated platelets in the small blood-clot are needed at the time of engraftment into the recipient. This is a critical step after centrifugation. Classic activation is by thrombin and calcium and known to haematologists and academics ( see Marx et al 2005). Thereby GF from the activated platelets will be released, albeit rapidly. This is not a bad thing. The application of unactivated-PRP, to a diseased tendon ( tendinopathy) or at surgery hoping for in-situ activation of the platelets by the patient's collagen may explain some poor early results or variable results not better than controls/placebo, seen in some trials. Because an unconventional PRP is being used. The right centrifuge, but the wrong or ineffective platelet-activation and therefor poor GF release. Non-activated PRP may well be of no value and no better than saline or placebo. The evidence for or justification for the clinical use of unactivated-PRP is poor and poor-results or outcome are predictable if this route is followed. Traditional physiological principles tells us that activated-PRP containing viable platelets, is needed. Most PRP generated in blood collection-tubes containing ACD-A or equivalent anti-coagulant, inhibit clotting by binding calcium ( Marx et al 2005). It is pointless to use such a solution alone,in the tissues hoping for regeneration or stimulation of healing processes. Can the collagen in the recipients tissues, neutralize the calcium-binding and at the same time activate the platelets to release GF? Probably not, and classically one needs to add a few drops of calcium/thrombin to activate the anti-coagulated PRP ex vivio, prior to application. This provides one with an excellent membrane ( Marx et al 2005). Injecting non-activated PRP into tissues and tendons , including the skin-dermis for rejuvenation in aesthetics seems pointless/counter-productive and achieving activation of " mesenchymal cells" resulting in tissue-regeneration or activating circulation-derived cells by this route seems unlikely and non-scientific. Activated PRP is imperative for the use in maxillo-facial surgery and orthopaedics (Marx et al 2005). One needs clotted, activated PRP that can be induced within 6-10 seconds. Interested persons are urged to review the work of Haynesworth et al who have documented ex vivo population growth of mesenchymal stem cells generated by the use of different concentrations of platelet containing solutions. Device selection for the generation of PRP and optimal platelet-yields is of great importance as recommended by FDA. Many generic devices do not come up to these standards. The use of un-activated PRP remains controversial and non evidence-based. What is needed is transfer of an activated PRP clot to the recipient site . PRP constructs also work well ( Marx et al 2005).

Branded products used in biological skin-rejuvenation in South-Africa: Derma-Roller®, Needle-Roller®, Citi-Roller®, Regenlab PRP®, MyCells®, Plateltex®, Neokit®.

TABLE 1: TECHNICAL PERFORMANCE ANALYSIS, STANDARDIZATION, COMPARATIVE  AND VERIFICATION DATA REGARDING PLATELET-RICH PLASMA ( A-PRP) OF VARIOUS PRODUCTS WITH THE SAME INTENT IN AESTHETIC FACIAL REJUVENATION . INCLUDES CELL-BIOLOGY DATA. ( After Du Toit,  Mazzucco et al and MJ Otto© 2009).

 

PARAMETER

 

REGEN®  A-PRP

 

CONTROL

 

MYCELLS ® A-PRP

Centrifuge-speed

Two spin: soft and high

3000 X 10 minutes

3,500 x 7 min

Plasma-yield

5 ml ( 8 ml tube)

5 ml

6 ml ( 10 ml tube)

Platelet-Activation 1

Calcium ( non irritant)

Calcium gluconate: non irritant

Vortex: non-activated PRP. Anti-coagulation not reversed.

Clear plasma separation

yes

yes

yes

PRP-gelation

Optimal

Rapid onset

Sluggish as anticoagulant not reversed with calcium or thrombin.

Platelet-recovery

Good ( Vox Sanguinis)

Good

Equivalent

ISO-clearance

Yes

Yes

Yes

CE Mark IIA Clearance

yes

yes

yes

Platelet-Activation 2.( After Otto©).

Calcium

Calcium

Adrenaline ( risk of cardiac arrhythmia)

Volumetric-effect

Not convincing

Not convincing

Not convincing

Skin-tightening

Not observed

Not observed

Not observed

Need for Accent RF after PRP

No: burn risk to client and over-servicing. No need for RF at time of intervention.Over-treatment.

No

 Yes ( Otto©)

Need for Dermaroller® after PRP

No. Risk of bruising, scarring, sepsis and cellulitis too high. Roller contraindicated after PRP injections because of infection risks. Over-treatment.

No

 Yes (Otto©)

Presence of CD-34+ BMSC in PRP

Yes: physiological

Yes: physiological

Yes ( Neocell Laboratories®).

Platelet-function: S test

Good

Good

No data

Pl. stimulation of BMSC in vitro

+ and exponential

+ and exponential

No data

Growth-factor content

Good ( published)

Good

No data

PDGF-AB ( Elisa) availibility

Good ( 140ng/ml): Vox Sanguinis.

Good

No data

Durable anabolic effect ( Vox Sanguinis)

Good

Good

No data

Ex vivo PRP  HSC stimulation ( vs pl.)

Good: published

Good

No data

Ex vivo PRP TC fibroblast proliferation testing.

Good: published

Good

No data

Ex vivo PRP TC ADSC proliferation testing.

Good: published

Good

No data

Ex vivo PRP TC keratinocyte proliferation testing, mesenchymal cell toxicity.

Good growth, no toxicity: published.

Good growth, no toxicity

No data

Cost ( two tubes)

R1600

R1750

R2600

Source: Du Toit et al. Int J Shoulder Surg 2007: 1; 64-73. Mazzucco et al. Vox Sanguinis 2008,2:1-5.  M.J.Otto©2009. Borzini P et al. ISBT Science Series 2007, 2: 272-1726.
Comment: PRP is classically used for the growth factor content and not stemcells. As far as we know the few CD34+ cells in peripheral blood and PRP are physiological as seen after  excersize and commited, thereby losing totipotency. There is no level of scientific evidence to suggest that these small numbers of CD34+ cells play any role in skin-rejuvenation. There are too few. Normally, to gain the benefit of BMSC, one would need a marrow aspirate to gain sufficient numbers of cells, but this approach is not ethically appropriate for skin-rejuvenation. Currently, it is not known if non-activated PRP works properly. Few products can show by cell-biology, that they can stimulate HSC ex vivo  in tissue-culture and that a product proliferation-ratio can be studied. Web-posting  and updating 31/3/2010

Publications:
1. Du Toit DF and Page BP. An in-vitro tissue-culture evaluation of the cell toxicity of Platelet-Rich- Plasma and silver dressings. Jnl of US-China Medical Science (USA). 2010.
Formulation: Biomedical Expert
Text formulation and posting: 4/3/2010
Disclaimer: This website provides no advice regards, medical or cosmetic conditions and treatment and accepts no responsibilities. Aesthetic clients should visit a reputable on-site aesthetic physician, dermatologist or plastic surgeon to discuss options and drawbacks and costs.

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Boland Cell - Cell Technology - Aesthetic Biotechnology