Brief description of the Celution procedure

In early 2000 it was found that in adipose tissue there are Mesenchymal cells and other regenerative cells (endothelial cells, smooth muscle cells, CD34 +) known as Stromal Vascular Fraction (SVF). This mix allows for cellular regenerative therapies due to multiple mechanisms of action, such as reduction of cell apoptosis, modulation of inflammatory processes and increased paracrine signal that increases angiogenesis and fibroblasts generation. In short, ADRCs (Adipose Derived Regenerative Cells) facilitate and promote the cascade of healing processes in an orderly and correct manner.

The researchers who published this discovery founded the company Cytori Therapeutics Inc., which is who makes the Celution equipment, the Brand has CE0086 and is designed to digest fatty tissue in order to remove, wash and concentrate stromal stem cells and other progenitor cells for autologous replantation. Likewise, the Celution system needs sterile consumables and an enzymatic reaction (both products have CE mark for use in conjunction with equipment for medical treatments)

Treatment and Dosage 1.0
1.1 Properties
Celution® System cellular output is 5 ml RL with ADRC, depleted adipocytes obtained lipoaspirate autologous tissue. The suspension of viable ADRC has been characterized with a viability of > 70% and an average yield of 4.2 x 105 nucleated cells per gram of fat, although naturally there is variability between patients.

1.2 Product Description  ADRC

Treatment for this study uses ADRC autologous fat tissue obtained from the patient by Celution® System. The Celution® System (Cytori Therapeutics, San Diego, CA) is an automated system that obtains concentrated ADRC after cleaning and processing fatty tissue from liposuction. The product is a cell suspension in a diluent. Its contents are nucleated and non-nucleated cells. Non-nucleated red blood cells (RBC) covering> 95% of suspended cells. Nucleated are approximately 0.1 to 5% of suspended cells.

Nucleated cells are> 70% viable and viable concentration of> 1.5 x 105 cells per gram of fat processed. Nucleated cells are present in the percentages: CD31 + / CD34 + (> 2%); CD34 + / CD31- / CD45 (> 10%); CD45 + / CD31- / CD 34- (> 15%). The combination of these three phenotypes are more than 90% of the nucleated cells of the product.

The last stage of processing with the Celution system is to reduce the level of reactive to safe levels. Studies conducted by the manufacturer and provided to the EU and regulatory bodies in the USA have determined minimal toxic levels and have validated that processing with Celution® reproducible system reaches these levels with a margin of robust security of at least 10-fold. The remaining noncellular component of the product comprises diluent is lactated Ringer solution.

2.0  Celution® System
2.1 Summary of cell preparation using Celution® System
Celution® System Prepare the ADRC output obtained by adipose tissue according to lipoaspirate standard practices. The tumescent fluid is normally composed of:
• 500 ml of Ringer Lactator
• 20 ml of 1% Lidocaine
• 1 mg of epinephrine

After obtaining tissue via liposuction, fat is introduced into a sterile canister for washing to and eliminate any harmful substance (such as cellular debris, anesthesia).

2.2 Intended Use
the Celution® System is manufactured for the digestion of human adipose tissue for future cleaning and concentration of Stromal Vascular Fractional and other progenitor cells for autologous replantation in the same patient in the same surgery.

2.3 Contraindications
1. Allogeneic use is contraindicated
2. The use of any other tissue than fat is contraindicated (see instructions for using the Celution® in the User Manual)

3.0 Treatment of Breast Reconstruction with enriched fat, as example
Breast cancer is the most frequently diagnosed cancer in women, with 22,027 cases each year. Of newly diagnosed cases of breast cancer, 70-80% can receive breast conserving surgery, which involves removing part of the breast followed by irradiation of the area. These women are often left with significant skin damage, tissue loss, pain and reduced arm movement as a result of current treatments.

These arguments describe the proposed implementation of a new technique for breast reconstruction enriched cells using the Celution 800 / CRS system by providing a choice of safe, predictable and sustainable reconstruction that overcomes the limitations of current procedures after breast cancer management, such as disfigurement, breast asymmetry, tissue loss and other complications.

This technique differs from traditional fat transfer that fat grafting is supplemented with autologous regenerative cells derived from adipose tissue. These cells are concentrated from lipoaspirate of the patient at the time of surgery and then to fat grafting are added before implantation.

Procedure

Initial clinical studies promoted by researchers indicate that there is a statistically significant improvement in the thickness of breast tissue and a high level of patient satisfaction with the procedure compared to traditional methods. This technique also offers the possibility of reducing the number of repeated interventions and reduced hospitalization, giving a new treatment option where current treatments are unsuitable or ineffective.

Treatment of patients with radiation injury is especially difficult. Traditional methods using reconstructive fat transfer often require additional treatments because graft retention is limited by the low vascularity of irradiated tissue. Breast reconstruction enriched with cells offers these patients a lasting reconstructive option that reduces the physical and emotional impact of breast cancer management restoring the natural appearance of the breast.

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