DAVID GRANOVSKY

Posts Tagged ‘FAILURE’

NOT FDA APPROVED, NOT INSURANCE COVERED SO IT MUST BE BAD!

In BUSINESS OF STEM CELLS, HOPE AND INSPIRATION, OFF THE BEATEN PATH, STEM CELLS IN THE NEWS on February 9, 2017 at 5:37 pm
failure-missed-opps

NOT FDA APPROVED, NOT INSURANCE COVERED SO IT MUST BE BAD!

Someone reminded me that most stem cell treatments and immunotherapies aren’t FDA approved or covered by insurance in the USA.
 
This is true, but…
we’ve known about the rampant capacity for stem cells regenerating/regrowing finger tips since the work of Dr Illingsworth in the early 70’s. Children under 8 regrew their fingertips unassisted. That was their natural stem cells in their own bodies regenerating the distal phalanx, blood vessels, skin, nail, etc. but our natural healing system is not FDA approved.
 
We’ve known about bone marrow derived stem cell treatments in the form of bone marrow transplants for Leukemia/blood cancers. They regrow the patients immune system and are approved and have been used successfully in the USA for 60 years.
 
We know of stem cell treatments recovering patients from many chronic and terminal diseases successfully around the world for over 2-3 decades but that is only outside of our country and medical system for what I think are probably obvious reasons.
 
We know immunotherapy, like the 2 bubble babies cured and out of bubbles in 2001 and the Cuban originated lung cancer vaccine has been working for decades and treated thousands successfully but that is years from getting approvals here.
 
Sadly, as you said, many of these treatments – which merely expand on and accentuate the natural regenerative capacity and natural immune response capacity of the human body – are not covered by insurance or FDA approved.
 
I guess the only question I have is:
If these treatments have worked years to decades everywhere else they are used…
Is this a failing of the treatments or of the FDA and insurance…

Only you can decide.

 
“Many of life’s failures are people who did not realize how close they were to success when they gave up.” – Edison

“All that was great in the past was ridiculed, condemned, combated, suppressed — only to emerge all the more powerfully, all the more triumphantly from the struggle.” – Tesla

“Success is not final, failure is not fatal: it is the courage to continue that counts.” – Winston Churchill

“The scientific man does not aim at an immediate result. He does not expect that his advanced ideas will be readily taken up. His work is like that of the planter—for the future. His duty is to lay the foundation for those who are to come, and point the way.” – Tesla

ELIZABETH TAYLOR DIES – CONGESTIVE HEART FAILURE – aged 79

In CELEBRITIES & STEM CELLS on March 23, 2011 at 1:09 pm

Elizabeth Taylor dies of congestive heart failure!!

A devastating loss to American and World culture, film and screen and one of the most cherished and greatest characters of our time.  What strikes me as particularly troubling is that perhaps it could have been avoided.  Elizabeth Taylor suffered from congestive heart failure since 2004.  Congestive heart failure has been treated successfully outside the USA since 2004…and I’ll bet she and her loved ones (all multiple millions of them)  had no idea that there were other options out there. Adult stem cell treatments can lower a congestive heart failure patient from stage 3 or 4 to stage 1 or 2, can double Ejection Fractions and can do so in about 70% of patients.  A tragic loss. -dg

Dame Elizabeth Taylor, seen here in 1953, has died in a Los Angeles hospital following a lengthy illness

Acting legend Elizabeth Taylor dies of congestive heart failure in hospital

  • Actress passed away from congestive heart failure after suffering from the condition since 2004

Elizabeth Taylor dies of heart failure in hospital aged 79 | Mail Online.

Her last show: Elizabeth was snapped celebrating her 79th birthday a month early in January before she was admitted to hospital a few days after

Her last show: Elizabeth was snapped celebrating her 79th birthday a month early in January before she was admitted to hospital a few days after

Stem Cells To The Rescue!

In VICTORIES & SUCCESS STORIES on February 22, 2011 at 7:04 pm

This procedure has been carried out for half a decade, safely and effectively, all over the world.  Is it any wonder the World Health Organization ranks the USA at 37countries below the top health care country in the world.  We need to catch up NOW! – dg

COLUMBUS, Ohio — For first time in the United States, one man’s heart has been saved by his own stem cells.

It’s an amazing medical breakthrough. The science behind the technique made it possible for a man to literally save his own life through his stem cells.

John Christy is the first person in the U.S. to have his own bone marrow stem cells injected into his heart to save his heart.

“All you’re doing is giving back to yourself something you already have,” said Christy

A Vietnam veteran was suffering from severe coronary artery disease.

“I was just thinking, ‘You’re getting old, you’re just tiring out and getting weary bones.’ I felt tingling. My legs had been swelling a little bit,” said Christy.

In one procedure, cardiothoracic surgeon Joseph Woo at the University of Pennsylvania School of Medicine is taking science from bench to bedside. After five years of research in animals, he is now retrieving stem cells from Christy’s bone marrow and using them to grow blood vessels around the heart.

“They form brand new micro blood vessels and deliver blood flow to the heart muscle,” said Woo.

He has started the first U.S. trial where stem cells are harvested during surgery, prepped and then re-inserted back into the patient’s own heart.

Results for Christy were seen almost immediately.

“I noticed two days after my surgery, I had much more ‘umph,'” said Christy.

It’s the same process that saved 76-year-old Christina McDonald, only it wasn’t arteries in her heart that were damaged. McDonald’s problem was in her legs.

“Sort of like a charley-horse where the muscles stiffen up,” said McDonald.

The arteries in her leg were clogged with plaque, putting her at risk for heart attack, stroke and amputation. Traditionally, doctors treat it with stents, angioplasties or bypasses. But now they’re using stem cells.

“We basically take stem cells from their hips to help grow blood vessels. It creates new, smaller blood vessels that give blood supply to the limb,” said Dr. Randall Franz, a vascular surgeon at Grant Medical Center.

It worked for McDonald. Three months later, her pain is gone.

The same goes for Christy. His only wish is that science was working faster. He lost his wife to heart disease one year ago.

“I wish that she could have had this,” said Christy.

A similar procedure is being done in Europe. The difference is Woo does his in one short surgery.

In Europe, it takes at least two procedures, weeks apart.

Woo says any patient who is a candidate for coronary bypass surgery is a good candidate for his stem-cell transplant.

Stem Cells To The Rescue! — Research Summary

CONGESTIVE HEART FAILURE: Congestive heart failure occurs when the heart’s ability to efficiently pump is impaired by a destruction or dysfunction of its muscle cells. The condition is a major health problem, affecting 4.8 million people — a figure that is rapidly growing as 400,000 new patients arise each year. A common cause of this condition is a heart attack, which strikes over a million people in the U.S. annually. Although many surgical, medical and technological methods exist to help treat patients with congestive heart failure, over half of the patients die within five years of their primary diagnosis. (SOURCE: stemcells.nih.gov)

STEM CELL POTENTIAL: Restoring the functionality of hearts damaged by congestive heart failure and heart attacks is one of the most challenging tasks doctors and surgeons face. Now, research has provided hope that adult and embryonic stem cells have the potential to replace the heart’s damaged muscle cells, as well as create blood vessels to route a steady supply of blood to them. To do this, heart muscle cells, such as the cardiomyocyte, which serve to push blood out of the ventricle, must be developed in order to improve blood flow and the transportation of oxygen and nutrients.

If extremely specific growth conditions are achieved in labs, then it is possible to leverage stem cells to develop new heart muscle cells. To test this concept, researchers forced a heart attack in lab rats and mice by attaching a ligature around a key blood vessel of their hearts in order to restrict the flow of nutrients and oxygen. Next, they tested the efficacy of a specific group of adult primitive bone marrow cells by injecting them directly into the damaged ventricle. To the researchers’ satisfaction, new cardiomyocytes, among other crucial heart muscle cells, began to form, leading the way for the development of a brand new system of coronary arteries, arterioles and capillaries. When compared to the control mice that also suffered heart attacks, but did not receive a stem cell treatment, the treated mice were found to be much more likely to survive. Research has shown high hopes that similar effects will blossom from human embryonic stem cells. Since embryonic cells can be coaxed into developing into any type of adult body cell, researchers hope to leverage them to take on the properties of cardiomyocytes and other cells. Embryonic cells aren’t the only solution, however. Under the right conditions, human hematopoietic stem cells are also able to transform into desired tissue types such as cardiac muscle. (SOURCE: stemcells.nih.gov)

A STEM CELL FIRST: Y. Joseph Woo, M.D., a cardiothoracic surgeon at the University of Pennsylvania School of Medicine performed a first-of-its-kind procedure in the United States. He took stem cells from a patient’s bone marrow (known as endothelial progenitor stem cells) and injected them into his heart during coronary artery bypass graft surgery. The patient felt relief almost immediately. A similar procedure is being done in Europe, but doctors there retrieve the cells while the patient is awake, which can be painful.


THE COST OF NOT PURSUING ADULT STEM CELL TREATMENTS IN THE USA

In VICTORIES & SUCCESS STORIES on February 9, 2011 at 9:40 am
COST BY DISEASE # OF PATIENTS COST PER YEAR
TYPE 1 DIABETES 5.8 MILLION PATIENTS $125.1 BILLION
STROKE 5.7 MILLION PATIENTS $62.7 BILLION
HEART FAILURE 5.2 MILLION PATIENTS $50.7 BILLION
SPINAL CORD INJURY 250,000 PATIENTS $37.2 BILLION
PARKINSON’S DISEASE 650,000 PATIENTS $23 BILLION

TOTAL COST THAT ADULT STEM CELLS COULD SAVE THE UNITED STATES

$250 BILLION PER YEAR


FELINE’S FAITHFUL FRIEND’S FUND FOR FAT FARMING FOLLOWS FRANKIE’S FUNCTION FAILURE…FOSTERS FUTURE FURRY FROLICKING

In STEM CELLS IN THE NEWS on August 3, 2010 at 9:00 pm

Gift launches fund for feline stem cell research, treatment

August 3, 2010

Colorado State University has announced the launch of a new fund devoted to feline stem cell research. Frankie’s Fund will fund research into how feline stem cells may be used to treat injuries and diseases in cats.

Generous gift from Frankie’s owner

Frankie’s Fund was initiated in July through the generous gift of a client whose 9-year-old Siamese cat, Frankie, became ill with acute kidney failure as a result of medication she received for an inflammatory mouth condition. Frankie participated in a CSU stem cell therapy clinical trial for cats with kidney failure in 2009.

“The establishment of Frankie’s Fund allows Colorado State University to continue to pursue stem cell therapy research and treatments for cats – something that is not widely available for cats. While such veterinary studies and treatments are available for dogs and horses at veterinary hospitals and clinics, including CSU’s equine stem cell programs, feline-focused programs are much rarer,” said Dr. Jessica Quimby, Frankie’s veterinarian at CSU.

“This fund allows us to develop our program and research to gain a better understanding of the biology of stem cells, how they function and what treatments they may offer for various feline diseases.”

Fund future clinical trials

Frankie’s Fund will support research and future clinical trials for stem cell therapy targeting acute and chronic kidney failure, inflammatory bowel disease and possibly asthma.

The fund is initially supporting a new study using stem cells to help cats with chronic kidney disease. The CSU Veterinary Teaching Hospital is looking for cats who have a stable disease status to participate. Cats in the study will receive injections of stem cells derived from the fat of healthy cats over several months. The study is open to cats from across the United States through coordination with local vets. Cats with some conditions, such as heart disease, kidney infections, kidney stones, inflammatory bowel disease or other complications cannot participate.

Chronic kidney disease is a common, progressive disease in older cats and there is no definitive treatment other than a kidney transplant. Recent laboratory studies have shown that stem cell therapy has the potential to improve kidney function and prevent scarring that forms in the kidneys as a result of the disease. The current study will explore repeated intravenous stem cell injections for kidney failure in cats.

Frankie died shortly before her 13th birthday

Frankie lived in Boulder until her recent death from cancer shortly before her 13th birthday. In December of 2009, Frankie was diagnosed with cancer and began a chemotherapy protocol developed by CSU. A kidney blockage precipitated total renal failure and she passed shortly before her 13th birthday. She was given home care for damage to her kidneys for several years before enrolling in the CSU program.

“Having lived in Boulder for decades I was well aware of the national reputation of Colorado State’s Veterinary Teaching Hospital,” said Deborah Felin Magaldi, Frankie’s owner. Magaldi is involved with several cat rescues and shelters and initiated the fund to help advance stem cell research for felines as well as humans. “Frankie was my best friend. She just happened to be a cat. Generously, she never held it against me that I was not.”

via Today @ Colorado State University – Gift launches fund for feline stem cell research, treatment.

Boston Scientific Corp. (BSX) suspend sales of medical devices that restore normal heart rhythm and manage heart failure

In BUSINESS OF STEM CELLS on March 15, 2010 at 8:01 pm

Pharma can’t seem to do anything right these days.  Falsified clinical trials, political agendas, now this. – dg

3rd UPDATE: Boston Scientific Slides On Halt Of ICD Sales

MARCH 15, 2010, 11:40 A.M. ET

Boston Scientific Corp. (BSX) suspended sales of medical devices that restore normal heart rhythm and manage heart failure, saying it failed to submit for U.S. regulatory approval certain changes in the way it makes the products.

The news sent Boston Scientific shares plunging 16% to $6.51 in recent trading. A big portion of the products affected–implantable cardioverter difibrillators, or ICDs, in the U.S.–represented about 15% of total company sales last year, and it’s not clear how long sales of the products will be suspended.

The documentation snafu is the latest setback for the Natick, Mass., company’s ICD business. Boston Scientific acquired Guidant in 2006 after reports of safety problems with Guidant’s ICDs, and Boston Scientific suffered years of negative fallout over the issue.

The news could also damage the credibility of the company’s new management team in the eyes of investors. “The announcement will weaken quality perception of a company that was on the brink of recovery,” Morgan Stanley analyst David Lewis wrote in a note.

On Monday, Boston Scientific said it stopped shipment and is retrieving inventory of all ICDs, as well as its cardiac resynchronization therapy defibrillators, or CRT-Ds. The company said it had found two instances of manufacturing changes that, while successfully validated, weren’t submitted to the U.S. Food and Drug Administration.

The errors put the company’s ICD devices out of compliance with FDA regulations, according to an analyst note from Bernstein Research. Boston Scientific said it plans to work closely with the FDA to resolve the situation, while saying it had no indications the manufacturing-process changes poses a risk to patients and it is not recommending that implanted devices be taken out…

Man Receives His Own Stem Cells as a Treatment for Heart Failure

In VICTORIES & SUCCESS STORIES on March 11, 2010 at 4:52 pm

THE TIDE IS TURNING

This story is HUGE.  No, not because a guy got better from stem cells…that’s been goi ng on commercially for half a decade around the world and was proven safe and effective in testing and studies on humans for over a decade.  What’s amazing about this story is that:

a human patient received ADULT stem cells in the US and the story was reported by a major US science publication in a positive light.

To explain;

  • for years the US news sources were unable or incapable or ordered not to publish any positive stories about ADULT stem cells.
  • There were falsely reported positive hyped stories about embryonic stem cell success everywhere…
  • There were positive stories about induced pluripotent stem cells…
  • then there were negative stories about induced pluripootent stem cells…
  • and when the negative induced pluripotent stem cell stories came out, someone decided to rename THOSE stem cells ADULT so as to confuse everyone and cast a negative light on ADULT stem cells…
  • and there were positive ADULT stem cell stories because you just can’t hold back the tide of positive stories from around the world – but these stories never ever had the word ADULT  associated with positive results so the reader had to assume the story was about embryonic…
  • but there were NEVER positive ADULT stem cell stories where the reporter called them ADULT stem cells.
  • This may in fact be the first!

WELL DONE! Keep up the good work!

Now maybe the US can start to catch up on using ADULT stem cells for treatment…seeing as how the EXACT content of this story has already been repeated around the world for almost a decade now. -dg

Man Receives His Own Stem Cells as a Treatment for Heart Failure

By Mandy Kendrick – Jul 27, 2009 03:45 PM

The first person to receive a new cardiac stem cell treatment in a U.S. Food and Drug Administration clinical trial is doing well, it was announced last week.

On Friday, doctors at the University of Louisville School of Medicine, in collaboration with the nearby Jewish Hospital, issued a press release stating that one week after treatment, Mike Jones’s heart was getting stronger.

Jones, whose heart tissue is permanently scarred and weakened by two previous heart attacks, suffers from congestive heart failure, a condition affecting about five million Americans each year, according to the National Institutes of Health.

Currently, two treatment options predominate for patients with heart failure, said Mark Slaughter, a cardiovascular surgeon who aided in the trial. A person can receive a heart transplant or a mechanically assisted heart device.

The new approach, using a patient’s adult stem cells to regenerate healthy heart tissue, is currently in phase I clinical trials to test for safety. The procedure consists of removing healthy heart tissue from the patient, purifying the stem cells from the material, and allowing the stem cell population to grow. Once ready, the stem cells are reintroduced into the scarred region of the heart using a minimally invasive technique.

Since the re-injection of his own stem cells on July 17, Jones’s heart has increased its ability to pump blood by about 5 percent. Jones commented in the University of Louisville School of Medicine press release that he felt so good he might “even start jogging again.”

The doctors will continue monitoring Jones every few months for the next two years to measure his recovery. There are currently 13 more patients going through the phase I trial, and the researchers hope to eventually test a total of 20 patients.

Last month, a group at the Cedars-Sinai Heart Institute in Los Angeles made news with a similar technique that was undergoing clinical trials.  Instead of using purified stem cells, the group is using a mixture of cells, including stem cells, to regenerate heart tissue. Ken Miles, the first patient to receive the treatment, told CBS’s The Early Show that he “feels great.”

%d bloggers like this: