Adipose Derived Stromal Vascular Fraction (SVF)

Pre-Clinical Study

Stem Cells have tremendous potential for healing. Stem cells by definition have the ability to develop into different types of cell lines and replace damaged or diseased tissue with new healthy tissue of the same type.

Stem Cell Abilities

For over 60 years, hematopoietic stem cells have been transplanted to heal hematological disorders. In the 1980s, embryonic stem cells became a controversial source for basic science and clinical research. In the 1990s research showed that mature adult cells have the potential to be converted back to a more primitive state. This required a series of complicated steps to unleash this more primitive potential. In the 2000s, subcutaneous fat was discovered to contain a high concentration of stem cells, up to 500 times more concentrated than in bone marrow. This high concentration along with easy and nearly painless availability has stimulated much research. The tissue derived from fat via aspiration (lipoaspirate) needs to be processed and concentrated. The processing uses an enzyme to release the regenerative cells trapped in the fat cell walls. The lipoaspirate after enzymatically treated and concentrated (stromal vascular fraction or SVF) contains a heterogeneous population that includes not only mesenchymal stem cells but other cell lines that have an effect on local tissue that reduces inflammation as well as stimulates local healing.

Treatment with autologous (our own) stem cells contained within SVF is a paradigm shift. In essence, we have within our own bodies cells that are held in reserve with the potential to heal ourselves. Through a 3mm incision under local anesthesia, a small amount of fat (about 50 grams) is harvested, then with minimal manipulation can be injected back an hour later not just as a band-aid, but with potential for real healing at the tissue level. There are many potential applications that are currently being studied. This includes treatment of arthritis, chronic wounds, heart failure, inflammatory conditions, bone regeneration for defects, nerve injury, and even chronic neurological conditions such as Alzheimer’s and multiple sclerosis. All of these areas are being actively investigated.

Four years ago we started a full-time research unit within our orthopedic hand unit. To date we have completed 2 of our own prospective randomized and controlled studies. We have participated in 2 pharmacy sponsored multi-centered research studies including a stem cell project for Pleuristem, an international Israeli-based company. We have performed 8 additional studies that have either been accepted or submitted for publication.

Last year we decided to focus our energies on the promising field of stem cell research and regenerative medicine. We started the Israel Stem Cell Solution. We submitted a proposal for using SVF for the treatment of painful knee arthritis. The Israel Ministry of Health is interested in us proceeding with this work but requires that we first perform preclinical testing to validate our methodology. We plan to use material from plastic surgery procedures and analyze the lipoaspirate to confirm our procedure. After completion of this preclinical phase, we will start the clinical trials, starting with treatment of knee. osteoarthritis.

Below is a list of the equipment needed that we will use for both the pre-clinical and the subsequent clinical study. Existing labs and personnel that are currently available at our hospital will do some of the testing. However, there is some essential equipment that must be purchased. Specifically this includes an automated processing system (from Korea) that takes the sterile lipoaspirate from the patient, adds the enzyme, washes and concentrates it in a closed sterile system so that it is ready for sterile reinjection. The other essential piece of equipment tests for endotoxin and is required to prove sterility immediately prior to reinjection.

Testing required for pre-clinical and clinical study:

• Sterility – based on gram stain and endotoxin testing
• Safety based on residual collagenase activity
• Cell populations based on immunophenotyping
• Cell count and viability
• Enzymatic versus mechanical isolation techniques

Testing equipment needed to purchase:

• ACS – automated cell station from Korea (including shipping) – $72,300
• Single use sterile kits for use in the ACS – $600/kit x 14 kits = $8400
• Endotoxin testing unit $18,070

Equipment and fees needed for additional testing:

• Immunophenotyping – $6677
• Collagenase and measure residue – $3611
• Mock run x 2 – $180
• Statistician – $250

Total needed for the study: $109,488

Donations:

Any donation received will be used 100% to purchase equipment (other than the required hospital research operating cost fixed at 17%). None of the money donated will be used for salaries or any research unit overhead.

Amount received to date from different donors:

$36,140

Amount Needed:

$73,348

To donate via 501c3 tax-deductible donation (Genesis Orthopedic Research) click here.