December 24, 2017

LipoVasCell

LipoVasCell®

LipoVasCell® as a biological product is produced under sterile conditions.  This product is also known as stromal cell vascular fraction (SVF) that is originated from the patient’s fat tissue as well as a combination of adipose stem cells-derived mesenchymal stroma cells (ASC-MSCs), endothelial progenitor cells (EPCs), B and T lymphocytes, and adipose tissue macrophages (ATMs). Firstly, adipose tissue samples are aspirated from patient’s sub-abdominal/buttocks that is followed by isolation of SVF cells using a standard enzyme digestion method.  Subsequently, a combination of isolated SVF-MSCs and the specified amount of the patient’s fat tissue is injected into the desire site. Growth factors and antibiotic are not used in this product.

Active substance

The active substance of LipoVasCell® is the autologous ASC-MSCs with the abilities of proliferation and differentiates into mesoderm categories, including bone, cartilage and fat. Furthermore, these cells have the ability to control the inflammation and immune responses, while they exhibit angiogenic property, through which new blood vessels form.

 

Excipient

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

 

Dosage form

LipoVasCell® is presented as a suspension, including a combination of ASC-MSCs and fat tissue. There are approximately 500000 cells per milliliter of adipose tissue that is determined based on the location of the lesion, total adipose tissue volume and the total number of cells.

 

Packaging

Sterile vial

 

Route of administration

Intra-dermal injection

 

Indications

LipoVasCell® can be used for treatment of soft tissue and skin lesions as follows:

  1. Improvement of the appearance of nasolabial folds, cheek, buccal area, and under the eyes
  2. Treatment of atrophic scars following radiation or chemotherapy
  3. Breast reconstruction after mastectomy

Autologous adipose tissue is considered as one of the natural filling material that is most commonly used to restore volume of soft tissue or skin. This method is also known as cell-assisted lipotransfer (CAL), in which adipose tissue samples are aspirated from patient’s sub-abdominal/buttocks, and after initial processing, the product is injected in desire area. LipoVasCell® is presented as an injectable suspension of ASC-MSCs and other stem cells that is added to autologous fat tissue for establishing a more durable effect and reducing the frequency of repeat injections.

 

Dosage

LipoVasCell® is exclusively prepared for every patient based on the areas and depth of wrinkles and lines, approximately 500000 cells per milliliter of adipose tissue, in one injection, but if it is needed to repeat the injections, there will be a three-month interval between the injections.  The effects of more than two injections have not yet been evaluated for this product.

Storage condition

LipoVasCell® 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. Implants in the areas receiving the cells
  4. History of allergy to animal proteins
  5. History of Botox injection during the last 6 months
  6. History of temporary fillers
  7. History of permanent fillers
  8. Use of laser therapy during the last six months

 

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. LipoVasCell® contains isolated autologous adipose tissue of a patient, so it is exclusively used 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 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

It is recommend the use of antibiotics, antiinflammatory and analgesics 3 days after injections as well as application of cold compress 24 hours of injections