ANDROGENETIC ALOPECIA (AGA)

Rafael Gálvez Ruiz, MD

This procedure is shown to be effective in delaying the biological evolution of Androgenetic Alopecia, as described in the scientific literature reported in the Bibliography section.

Specific considerations for patients undergoing “DERMIS MICROGRAFTS WITH RIGENERACONS FOR ANDROGENETIC ALOPECIA” protocol:

Patient suffering androgenetic alopecia must have enough hair follicles (hypotrophy) and a small bald pate area.

• The scalp should look healthy.

• Absence of local inflammatory pathology must be assured.

• Normal blood analysis (TSH below 2).

• A healthy food intake is ideal.

• Graft must be procured from a standard/healthy hair follicle area.

• Anesthesia without adrenaline and in a surrounding fashion (resembling a peripheral blockage and avoiding embibing the donor dermis).

PRE-PROCEDURE CONSIDERATIONS:

Clinical record is mandatory in accordance to local laws and requirements, although this is a minimally invasive medical procedure. Signed consent is required, like in any other aesthetic medicine procedure. Its characteristics will be subjected to the local laws. Thus, it is important that the physician is acquainted with them.

Pictures must follow a previous stablished guideline. Light, distance to focus, zoom, and camera from the pre-treatment photo must be the same for all the follow-up photo(s), so they can be compared.

PROCEDURE:

A. Prepare the patient:

I) Protect the surgical field. Although this is an ambulatory procedure and, could be performed outside an operating room, sterile handling of the sample must be guaranteed at all times.

II) Micrograft will be extracted from the mastoid hairy area, containing the Hair Follicle complex.

B. Prepare the equipment:

I) Rigenera® Machine N4SA: The machine must be plugged-in to the electrical power source. Turn it on. Be sure that the engine lever is up.

II) Rigeneracons® device: Peel the protective shield and discard it. Only the Rigeneracons® device, inside the second cover, is sterile.

III) Disposable material: Leave it on an accessory table. The whole set must be ready-to-use and kept sterile.

C. Prepare yourself:

I) Good light.

II) Goggles (optional).

III) Sterile gloves.

D. Biopsy retrieval:

I) Mark retrieval area, using a standard dermis marker.

II) Disinfect the retrieval area with the antiseptic solution of your choice (e.g.: alcohol 70% or Chlorhexidine ).

III) Anesthesia application in the periphery area without embedding the donor tissue (e.g.: 2% lidocaine without vasoconstrictor).

IV) Shave gently to remove the stratum corneum. Extract the samples with a dermal punch. Normally, the procedure will require 3 samples with a 2.5mm punches minimum.

NOTE: Using a 3- or 4-mm diameter dermal punches might require stitches.

E. Sample procurement:

The procedure is standard and extremely simple. However some complications, related with the small size of the sample, are relatively frequent:

• The tissue might stay inside the incision covered with blood. The tissue might stay inside the dermatome (dermal punch). It could be extracted with a needle.

• The tissue might get washed away by the blood.

• Mechanical compression is enough as hemostatic technique. Exceptionally, a stitch might be required.

F. Sample processing and micrograft solution generation:

I) Place the biopsies inside the Rigeneracons® device, over the grid under the helix rotor.

II) Add 1.2 ml sterile injectable physiologic solution through the specific connector of the Rigeneracons® with a non-Luer Lock® syringe. NOTE: The Grid has to be wet and the sample must slightly embedded, not submerged in it

NOTE: If more sterile saline solution has been used and the sample float into it we suggest to aspirat and discard the excess of saline solution.

III) Close the Rigeneracon® and place it in the Sicurlid, that could be sterilized if needed, couple the device with the Sicurstik.

IV) Place it in the Rigenera® N4SA machine rail into the main body and couple it with the machine rotor.

V) Press the central button located in the machine front. For this specific protocol the sample should be disaggregated for 2 minutes, each pulse lasts 1 minute (1minute/pulse).

NOTE: A green led will indicate that the process has started. It is automatic and it lasts 1 minute.

VI) Collect approx. 1.2 ml of micrograft solution through the specific connector of the Rigeneracons® (PRE-VIAL 1, more concentrated). Avoid using non-Luer Lock® syringe.

VII) Repeat steps from “ii” to “vi” with the same Rigeneracon® and sample to obtain (PRE-VIAL 2, more diluted).

VIII) Pull together and mix PRE-VIAL 1 and PRE-VIAL 2 in a 3 ml Luer Lock® syringe, the approx. micrograft solution volume is 3 ml.

XI) Split the volume into another 3 ml Luer Lock® syringe with a transfer (1.5 ml in each)

X) Increase the volume up to 3 ml with sterile injectable physiologic solution in both syringes, this syringe is now ready to use.

NOTE: 6ml of micrograft solution is enough for the Androgenetic Alopecia treatment of the damaged scalp area.

G. Application through mesotherapy:

I Injection will be performed with a 30G of 4 mm needle.

II The micrograft injection is performed both perpendicularly than with a moderate inclination to the scalp, depending on skin thickness. The solution should be injected in a superficial subcutaneous plane/deep dermis and not strictly intra-dermal .

III The injections shall be approximatively 0.05/0.1 ml* cm2

NOTE: 6ml of micrograft solution is enough for the Androgenetic Alopecia treatment of the damaged scalp area.

PRE-PROCEDURE CONSIDERATIONS:

• Hemostasis is achieved by mechanical compression. Normally, stitches are not needed. If necessary, put one stich

• Vicryl rapid 4/o for each incision.

• After the procedure, pictures must be taken under the same conditions from the preoperatory

• Avoid activities that increase blood hydrostatic pressure he first 48 hours: sport, yoga, sauna, etc.

• Wound hygiene should be controlled.

• Sun protection is mandatory.