RecolorCell ® as a biological product is produced under sterile conditions. The active substances of this product are melanocyte, producing melanin, and keratinocytes, transferring uniformly the pigment cells to the surface of the skin, that are obtained from the epidermis layer of the patient’s skin in gluteal region (buttocks) using a standard enzyme digestion method. RecolorCell ® is applied for vitiligo patches through an intradermal injection.
The active substances are autologous keratinocytes and melanocytes with abilities of proliferation, melanin production and transfer of the pigment cells to the surface of the skin.
This product contains normal saline (sodium chloride 0.9%) as the base solution.
RecolorCell ® is presented based on patient’s skin color, level of sun exposure and the race. It means that a cell suspension with different number of cells, approximately 70,000 cells per square centimeter area of vitiligo patches, is exclusively prepared for a patient.
Route of administration
Intradermal injection into the vitiligo patches
This product can be used in the treatment of different types of vitiligo with the following patterns:
This product is effective for an area of less than 200 cm2 and for injections in all parts of the body (even eyelids and genitals). This product has a slow onset of action and its effect appears gradually.
RecolorCell ® is exclusively prepared for a patient based on the areas of his/her body affected by vitiligo, approximately 70,000 cells per square centimeter area of vitiligo patches, in one intradermal injection.
RecolorCell® should be stored at 2 to 8 °C, away from direct sunlight. It should also be used in 12 hours after production to prevent loss of product efficacy.
This product is not recommended in the following cases:
- Use of cytotoxic or immunosuppressant drugs
- Different types of cancer
- Use of laser therapy or UV phototherapy during the last six months
- Presence of cellulitis or infection in vitiligo patch
- History of allergy to animal proteins
- Progressive vitiligo
- Inactive vitiligo for less than a year
Use of this product has not been evaluated in pregnant women; therefore, not recommended.
Use of this product in patients under 18 years old is not allowed.
It is not recommended if the package is damaged or if the expiration date has passed.
Allergy, inflammation and edema at the injection sites may occur in people using the product in the first 24 hours after the injection. Tumor formation has not yet been reported.
The injection site is pressed for a minute following injection, but it does not need a dressing. It is best to use an insulin syringe for injection. Patient can wash the site right after the injection. Cold compress on face is recommended for reducing erythema or swelling after the injection. Furthermore, topical anesthetic is suggested prior injection to control pain.