WHAT ARE STEM CELLS?

All live cells have the ability to duplicate and multiply. A stem cell has an additional property - the ability to turn into other types of tissues.

As such, stem cells may be able to repair damaged tissue by transforming into replacement cells and tissues. Stem cells have also exhibited anti-inflammatory and immune-modulatory properties in lab tests and clinical trials.

Early research focused on embryonic stem cells. Having grown from a single cell, the embryo consists mostly of undifferentiated stem cells. These cells follow DNA instructions to multiply and transform into skin cells, muscle cells, nerve cells, organ cells, and all the tissues of the completed human body.

The use of this embryonic tissue was extremely controversial. The ethical concerns raised by the use of unborn or unwanted embryos for research or treatment received so much publicity that many people associate ethical suspicions with all stem cell research. However, embryonic stem cells are not widely used in treatment or research anymore.

Dr. Lekkos uses “adult stem cells,” meaning stem cells that remain present in a live-born human being of any age. Such cells can be extracted and deployed back into the body without danger to the patient. With an boost from technology, the patient’s own natural healing and reparative properties are enhanced by these cells.

Modern tools allow Dr. Lekkos to separate large numbers of stem cells from fat. These prolific stem cell reserves show the most promise for stem cell therapy as a non-invasive, affordable outpatient procedure to treat a wide variety of conditions resulting from disease or serious injury.

COLD STORAGE OF STEM CELLS

Adipose-derived stem cells can be cryo-preserved in cold storage at the time of harvesting. Cryopreservation of stem cells is a joint project between Cells On Ice™ and American CryoStem. Either the complete fat sample, or just the Stromal Vascular Fraction (SVF - the tiny fraction of a fat sample that contains vast quantities of stem cells) can be frozen.

Choosing cold-storage for a portion of their fat or SVF specimen would allow patients to have a steady supply of their own stem cells on hand to treat anything from heart attack, stroke, serious accident, possibly even some cancers.

Certain neurodegenerative and autoimmune conditions require multiple treatments. Preservation through Cells On Ice™ makes these multiple deployments easy and cost-effective.

ABOUT REGENERATIVE MEDICINE

Regenerative medicine is the process of replacing damaged or defective tissue with functioning, living replacement tissue to restore organ functions lost due to damage or disease.

Traditionally, this involved stopping disease and helping the body repair itself, through medication and hormone therapy. Genetic research has also allowed doctors to treat degenerative diseases caused by gene defects.

Adult Mesenchymal stem cells hold great promise in regenerative medicine. Studies suggest the ability of such cells - the patient’s own tissue - to stimulate a natural repair process in previously irreparable organs, allowing them to heal themselves.

Stem cells use complex molecules called cytokines, or “growth factors,” to communicate with tissues and each other. Thousands of growth factors are currently used for therapeutic and cosmetic purposes, some with FDA approval.

The science of combining stem cells and growth factors in treatment of degenerative diseases represents a promising frontier in regenerative medicine.

HOW DO ADULT STEM CELLS REPAIR DAMAGED TISSUE?

Adult stem cells remain dormant until they witness injured tissue, which they discover through cytokine communication. At this point, they become activated. It is unclear whether they transform into differentiated tissue that can replace the damaged tissue, or if they send out signals to stimulate some other healing mechanism.

Human evidence and animal models demonstrate that stem cells tend to seek out areas of need and stimulate the repair process.

WHAT KINDS OF DISEASES OR DAMAGE CAN BE TREATED?

Stem cell therapy shows promise to alleviate many degenerative, congenital, autoimmune, and trauma-induced conditions.

That said, every body is different, and every condition has different properties. Each individual case must be evaluated for the potential efficacy stem cell therapy.

Each patient must be medically cleared, even though the procedure is minimally invasive.

IS YOUR TREATMENT APPROVED BY THE FDA?

No. However, certain procedures that manipulate the patient’s own tissues fall under “physician’s practice of medicine” rules and can be undertaken with the patient’s consent.

The FDA requires that such treatments be same-day procedures for both extraction and deployment, using the patient’s own, unmanipulated cells. Dr. Lekkos meets all of these guidelines with his treatments.

DOES DR. LEKKOS USE EMBRYONIC STEM CELLS?

No, embryonic stem cells are not used in human trials or experimental treatments due to ethical concerns. FDA regulation only allows re-injection of a patient’s own stem cells. The cells are obtained from the patient’s own fat tissue on the day of the procedure, just prior to deployment.

DOES DR. LEKKOS USE STEM CELLS FROM ANIMALS OR OTHER PEOPLE?

No, only the patient’s own stem cells are used. This not only complies with FDA requirements, but poses the least risk of contamination or rejection, since the body is receiving no foreign tissue.

WHY DO PATIENTS ASK FOR STEM CELL TREATMENT

Stem cell treatment offers promise for relief of serious degenerative conditions. Many patients have been told that surgery, and other risky or invasive treatments, are their only option to alleviate symptoms.

Many have heard or read compelling testimonials or experimental results. Such testimonials should be noted with caution, as investigations are ongoing.

The availability in the U.S. of experimental protocols for autologous stem cell treatment creates an affordable, convenient alternative to off-shore treatments, which can run from $20,000 to $100,000.

HOW DO YOU OBTAIN MY STEM CELLS?

A minimally-invasive liposuction procedure extracts less than 100 cubic centimeters of fat from the patient’s body, usually from the abdomen area. The procedure takes about 20 minutes.

One cubic centimeter of fat can yield between 500,000 and 1,000,000 mesenchymal stem cells. One extraction typically yields 10-40 million stem cells.

Post-operative discomfort and limitation activity is minimal.

CAN STEM CELL THERAPY GIVE ME CANCER?

Adult mesenchymal stem cells have shown no propensity to cause cancer.

Embryonic stem cell treatments, conducted outside the U.S., occasionally resulted in tumors known as “teratomas.” This gave rise to stories that “stem cells cause cancer.” However, these tumors are not cancerous, and Dr. Lekkos does not use embryonic stem cells. Adult stem cells have never been shown to cause tumors.

WHAT IF I HAVE HAD CANCER?

Stem cell therapy is not known to affect dormant cancers. There is no reason to withhold stem cell treatment to a patient in remission from cancer.

Stem cell treatment is usually not recommended to patients with active cancer.

HAVE ADULT STEM CELLS EVER HARMED HUMAN OR ANIMAL SUBJECTS?

All patients receiving stem cell treatment have been entered into the International Stem Cell Registry to track adverse effects.

No cases of serious harm to a human or animal as a result of adult autologous mesenchymal stem cell treatment has been documented.

Isolated reports of complications from procedures in other countries are under investigation by epidemiologists to determine the true cause of those complications.

Of over 1,000 entries into the International Stem Cell Registry, complications have occurred in only 2% of treatments, none of them “serious adverse events.”

HOW ARE THE STEM CELLS DEPLOYED INTO A PATIENT?

Stem cells may be injected into veins, arteries, spinal fluid, subcutaneously, or directly into organs and joints, all minimally invasive procedures. It depends on the condition to be treated.

Stem cells injected into the bloodstream tend to seek out areas of damage, and have been observed to cross the blood-brain barrier, where they have potential to stimulate repair of the central nervous system.

WHEN CAN I EXPECT IMPROVEMENT AFTER TREATMENT?

Possibly quickly, possibly never. Every condition is different, and every person responds differently. Some patients may see dramatic improvement; others none at all. Regeneration of joint cartilage may not manifest for several months after treatment.

This is uncharted territory - promising territory, but with too little evidence amassed for there to be a clear roadmap to success.

FDA regulations prohibit us from certain claims to the benefits of stem cell therapy, or the expectation of results.

If selected for stem cell treatment, Dr. Lekkos will explain that stem cell therapy may provide relief or remission of symptoms, but results are uncertain and treatment would be considered investigational.

DO YOU GUARANTEE THAT I AM A CANDIDATE?

No. Only certain medical conditions are eligible, and each case is evaluated on an individual basis.

Patients must be medically stable enough to be treated in our facility. Some conditions may be too severe for treatment.

ARE ANY PATIENTS DECLINED AUTOMATICALLY?

Yes. Any active infections must be treated first. Patients with uncontrolled cancer are not candidates for stem cell therapy. Severe illnesses, bleeding disorders, and patients taking blood-thinning medications require special evaluations before they can be considered a candidate.

WHAT IS INCLUDED IN THE COST?

Our fee covers stem cell harvesting preparation, and injection. It may also include the use of advanced interventional techniques. A complete evaluation is necessary before the total cost can be assessed?

ARE MULTIPLE TREATMENTS NEEDED?

For many patients, one deployment is enough, especially in the case of orthopedic conditions.

Auto-immune diseases and certain other degenerative conditions may require a series of injections.

Additional treatments will be considered on a case by case basis, with financial considerations factored in.