When Rand McClain, D.O. heard the story of a 63-year-old Florida woman whose life was saved by fat stem cells, it was yet one more piece of what he considers to be overwhelming medical data demonstrating that fat stem cells effectively treat, and in some cases cures, dreaded diseases.
Yet at the same time, the Santa Monica, Calif. based rejuvenation medicine specialist and Medical and Scientific Advisory Board member at American CryoStem (OTCMKTS: CRYO) had a visceral reaction as well: anger. Because part of that very procedure that saved this woman’s life, and has extended the lives of countless others that he knows around the world, is not yet approved in the United States.
While it’s okay to collect and transport adipose tissue (fat) and cryopreserve the pure tissue for further use as a natural filler, the FDA has not yet approved reintroducing the isolated healthy Mesenchymal cells contained in your tissue into your body, a process known as stem cell therapy, even when it’s your own (autologous) biological material.
Let’s back up.
The magazine STAT just published an exclusive, feature-length story on Jeneen Leogrande, 62, and how belly fat saved her life. She had undergone lung surgery, removing her entire right lung, part of her chest wall and two ribs, but soon developed complications and started leaking air from her fistula. “She leaked air so badly she struggled to speak and breathe,” the magazine reports.
After three years and 30 surgeries, nothing worked. Doctors gave her little time to live. Today, she is still alive because the miracle treatment performed at the Mayo Clinic in Minnesota where a procedure who’s key bio-material was derived from her own fat stem cells extracted from her belly. Leogrande became the first patient to have her fistula repaired with her own stem cells. It was later written up by the Mayo Clinic in the journal Stem Cells Translational Medicine. “I feel like I was given a third life,” Leogrande told STAT. “I’m hoping this is the start of many, many more people benefitting from my surgery.”
While extraction of fat stem cells, known as adipose tissue derived stem cells (ADSC’s), is permitted in the U.S., the process of reinjecting your own stem cells into your body is not yet approved. In Leogrande’s case, a compassionate use special waiver, from the FDA was needed to make it happen in the US. Others have chosen to go to foreign countries to have their own stem cells used for therapy.
While the doctors who performed the procedure stop short of crediting stem cells for closing the fistula, Dr. McClain says the evidence he’s seen and medical data from all over the world is overwhelming.
“We have plenty of evidence to show use of fat stem cells work to correct many pathologies, and most importantly, we have a good understanding how they work to do so,” says McClain from American CryoStem. “Stem cell treatments work – and have been used in one form or another since 1970’s.”
He says there are so many success stories you can’t even count them. CNN profiled the story last year of then 23-year-old Sarah Hughes who suffered from systemic juvenile idiopathic arthritis, a debilitating autoimmune disease. After trying everything her whole life, she turned to stem cells that involved treatment in Mexico and within two hours noticed a difference. After one year of treatments, she no longer needed chemotherapy or maintenance drugs. It has taken 2.5 billion of her own stem cells to date, and she will be evaluated again in 2017.
“I have hope now, and I didn’t have that before,” Sarah told CNN. “My life is 100% different.”
Utilizing adipose (fat) derived adult stem cells is a promising treatment for patients who want to slow the progression of the disease and its symptoms, according to American CryoStem (CRYO). Studies have shown fat stem cells to be effective at treating Crohn’s disease, pulmonary disease, Parkinson’s and various auto-immune diseases. It also has been shown to treat Alzheimer’s, Rheumatoid arthritis, multiple sclerosis, ALS, spinal cord injuries, coronary artery disease and a whole host of orthopedic applications.
Currently, there are multiple studies ongoing globally that involve adult mesenchymal stem cells, which exist in bone marrow and fat. “Even as we speak, American CryoStem is leading the way in this area of harvesting, transporting and storing fat cells, particularly with people who have a family history of lung disease, heart disease, MS, stroke, cancer and diabetes,” says John S. Arnone, Chairman of American CryoStem. “People who have a family history of illness, or an orthopedic injury are typically more proactive in storing their stem cells as an insurance policy, even before they show any signs or symptoms.”
The FDA guidance policy(s) is currently under review due to the outcry from physicians and patients looking to use their own biological material to heal and repair themselves. “I see it every day how stem cells are saving lives,” says McClain. “I am convinced that fat stem cell therapy works. I know it saves lives and improves quality of life. I see it in the studies and anecdotally.”
This September the FDA is expected to begin hearings relating to the regulation of Human Tissue Cells. As the FDA reviews its guidance related to Adipose derived stem cells, American CryoStem expects to see the number of people storing their stem cells for personalized regenerative medicine grow steadily. In the interim, American Cryostem says it has developed working relationships with medical facilities in the Cayman Islands, Costa Rica and other countries for Americans who want to undergo stem cell therapy and don’t want to wait.
For more information about American CryoStem, please visit AmericanCryostem.com or phone 732-747-1007.
SOURCE: American CryoStem
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