December 24, 2017

RenudermCell

RenuDermcell®

RenuDermcell® as a biological product is produced under sterile conditions. The active substance is the cultured fibroblasts isolated from the dermis layer. Firstly, a small sample is taken from the skin behind the patient’s ear. Subsequently, the fibroblasts are isolated from the skin sample using a standard enzyme digestion method and proliferated using a standard medium.

 

Active substance

The active substance is autologous fibroblasts from the dermis layer of skin behind the patient’s ear with abilities of proliferation and secretion of type 1 cologne in order to repair the skin. 

 

Excipient

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

 

Dosage form

RenuDermcell® as a cell suspension is presented in the following form: 10/1-containing 10 x 106 autologous fibroblasts in 1 ml sterile normal saline (sodium chloride 0.9%).

 

Packaging

Sterile vial

 

Route of administration

Intra-dermal injection

 

Indications

 RenuDermcell can be used in the following cases:

  1. Improvement of nasolabial folds
  2. Treatment and improvement of acne holes
  3. Treatment and improvement of atrophic depressed skin lesions following skin trauma (injury)

 

Therapeutic mechanism of action

The injected fibroblasts cause an increase in extracellular matrix proteins and collagen synthesis that leads to skin regeneration. This product has a slow onset of action and its effect appears gradually, while the duration of effect has been reported for a period of four years. This produce is mainly used to improve mild to severe nasolabial folds in adults.

 

Dosage

RenuDermcell® contains 5 x 105 to 6 x 105 cells per 1 cm of wrinkle line of desired area. Three injections are suggested with a time interval of 1 month between injections.

 

Storage condition

RenuDermcell® 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. History of Botox injection/temporary filler injection during the last 6 months
  4. History of permanent fillers
  5. History of laser treatment during the last 6 months
  6. Pregnant and lactating women
  7. Children under18 years old
  8. Use of allogeneic product (non-self)
  9. Local and systematic infection

 

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.

 

Seniors

Use of this product is not recommended in individuals older than 65 years.

 

Warning

It is not recommended if the package is damaged or if the expiration date has passed. Furthermore, RenuDermcell® is produced by the skin cells of patient’s ear, so it is used exclusively for the same patient. This product cannot be used for other patients because it causes severe allergic reactions.

 

Side effects

Allergy, inflammation and edema at the injected sites may occur in people using the product in the first 24 hours after the injection. Tumor formation has not yet been reported. The most common serious side effects reported by more than 1% of patients are local reactions at the injection site including redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis, and itching.

 

Medical advice

Low to moderate allergic reactions may occur following injection, especially swelling and inflammation at the injection site. If there is no major problem, patient does not require special care or treatment. Otherwise, the use of anti-inflammatory drugs or intramuscular injection of dexamethasone is recommended.

The following steps need to be considered after the injection:

  1. Apply a cold compress to reduce swelling and discomfort at injection site for 2-3 minutes if necessary.
  2. The injection site should not be washed for at least 24 hours.
  3. The injection site should not be massaged for at least 72 hours.
  4. Use of any health/beauty products is not recommended for at least 72 hours after the injection.