December 24, 2017

MesestroCell

MesestroCell®

MesestroCell® as a biological product is produced under sterile conditions.  This product contains autologous bone marrow-derived mesenchymal stromal cells (BM-MSCs).  Firstly, BM fluid is aspirated from the back of a hip bone (iliac crest) of a patient and isolated BM-MSCs are cultured in a standard environment.

 

Active substance

The active substance of MesestroCell® is autologous BM-MSCs with the abilities of proliferation and differentiates into mesoderm categories, including bone, cartilage and fat. These cells also control the inflammation and immune responses, differentiate into vascular cells, and 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

MesestroCell® is presented as a cell suspension in the following form: 20/3-containing 20 x 106 autologous BM-MSCs in 3 ml sterile normal saline (sodium chloride 0.9%).

 

Packaging

Sterile vial

 

Route of administration

Intra-articular injection

 

Indications

Osteoarthritis of the knee, hip, ankle and hip

 

Dosage

MesestroCell® is a cell suspension containing 20 x 106 autologous BM-MSCs in 3 ml sterile normal saline (sodium chloride solution 0.9%) for one direct injection into knee joints, 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

MesestroCell® 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. Hyaluronic acid gel injections of the knee joint in the last month
  4. History of allergy to animal proteins

 

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. MesestroCell® contains autologous BM-MSCs 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.  Furthermore, the similar studies have reported no tumor formation or no side effect after using the product for 11 years.