December 24, 2017

RecolorCell

RecolorCell ®

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. 

 

Active substance

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.

 

Excipient

This product contains normal saline (sodium chloride 0.9%) as the base solution.

 

Dosage form

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. 

 

Packaging

Sterile vial

 

Route of administration

Intradermal injection into the vitiligo patches

 

Indications

This product can be used in the treatment of different types of vitiligo with the following patterns:

  • Focal
  • Segmental
  • Generalized

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.

 

Dosage

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. 

 

Storage condition

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.

 

Contraindications

 This product is not recommended in the following cases:

  1. Use of cytotoxic or immunosuppressant drugs
  2. Different types of cancer
  3. Use of laser therapy or UV phototherapy during the last six months
  4. Presence of cellulitis or infection in vitiligo patch
  5. History of allergy to animal proteins
  6. Progressive vitiligo
  7. Inactive vitiligo for less than a year

 

Pregnant women

Use of this product has not been evaluated in pregnant women; therefore, not recommended.

 

Children
Use of this product in patients under 18 years old is not allowed.

 

Warning

It is not recommended if the package is damaged or if the expiration date has passed.

 

Side effects

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.

 

Medical advice

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.