Category Archives: Stem Cell Therapy

OTTAWA A team of Ottawa researchers has been awarded $442,000 to test the worlds first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream thats notoriously difficult to treat.

The federal grant will allow researchers from the Ottawa Hospital Research Institute to use mesenchymal stem cells, found in the bone marrow of healthy adults, to treat as many as 15 patients with septic shock.

The deadly infection occurs when toxic bacteria spreads rapidly throughout the body and over-activates the immune system, leading to multiple organ failure and death in up to 40 per cent of cases.

One in five patients admitted to intensive-care units suffers from septic shock, making it the most common illness among a hospitals sickest of the sick.

Existing treatments focus on early diagnosis and intervention before organs start to fail. Patients with septic shock require aggressive resuscitation measures, large doses of intravenous antibiotics and, often, ventilators to help them breathe.

Yet because the infection can creep up on patients rapidly and cause unpredictable complications, death from septic shock remains relatively common.

The experimental therapy aims to use donor stem cells, grown and purified at the Ottawa laboratory, to dial down the bodys hyperactive immune response and reduce the cascade of inflammation that leads to organ failure.

Early results from animal studies even raise the possibility that mesenchymal cells could eliminate the bacteria that causes septic shock, although the impact on humans is not yet known.

Its a unique feature of the stem cells, said Dr. Lauralyn McIntyre, the intensive-care physician who is leading the trial. Certainly no other therapy in the past, other than antibiotics, has impacted the bacterial load in the system.

Like other stem cells, mesenchymal cells can turn into a variety of more specialized cells and tissues that help repair and regenerate damaged organs. And because mesenchymal cells are derived from adults, they sidestep the ethical issues arising from the destruction of human embryos needed to make embryonic stem cells.

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Ottawa researchers receive grant to test stem-cell therapy for septic shock

The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law.

In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year.

"It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells."

An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously.

Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest of doctors who later reinject them into patients.

Dr. Stanley Jones, a Houston orthopedic surgeon, injected Perry's stem cells during his back surgery in July.

The plan by Celltex and Perry to make Texas a leader in the therapy have been controversial since details about the governor's procedure became known last summer. The therapy, drawing on the ability of adult stem cells to replenish dying cells, is promising but thought by most medical researchers to need much more clinical study before it is commercialized.

Stem cells are a kind of medicine known as biologics, therapy involving living cells rather than chemicals. Most medical experts say that adult stem-cell therapy involves more than the "minimal manipulation" the agency allows without its oversight because the cells are isolated, cultured in a laboratory and stored for some period of time before being reinjected.

The FDA has recently stepped up enforcement of unregulated adult stem cell activity, though legal experts interviewed last fall by the Chronicle said it was unclear whether the agency would look into Perry's procedure because he seemed fully informed and unharmed by it.

The Texas Medical Board is currently considering a policy that would require providers of stem cells and other experimental drugs to use them only with the permission of independent review committees that assess trials for patient safety. The policy comes up for final approval in April.

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Perry's stem-cell firm draws FDA scrutiny

(CNN) -

A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

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Patient dies during procedure

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today discussed the potential use of the companys cell encapsulation technology with modified stem cells to treat late stage cancers.

Stem cell therapy is not new to physicians dealing with blood and bone cancers, with stem cell transplants being an important treatment for growing new bone marrow since the 1970s. Recent studies have indicated the potential for using stem cells across a much broader range of cancers is becoming a reality, mostly a result of advances in cell and molecular biology techniques.

Traditional chemotherapy works by targeting the fast-growing cells common to cancer tumors. Unfortunately, chemotherapeutics dont differentiate between healthy and cancerous cells. Patients suffering from metastatic cancers, where tumors have spread to multiple areas of the body, often have substantial difficulties with the chemotherapy needed to treat their disease.

In one case, researchers at City of Hope and St. Jude Children's Research Hospital may have found a way to treat cancers that have spread throughout the body more effectively. They used genetically modified stem cells to activate chemotherapeutic drugs at the tumor sites, so that normal tissue surrounding the tumor and throughout the body remain relatively unharmed. The stem cells were designed to produce a specific enzyme that converts the nontoxic prodrug into the chemotherapeutic agent. This method also targets the brain tumor treatment to remain localized within the brain, similar to the pancreatic cancer clinical trial carried out by SG Austria, providing for high dosage chemotherapy without affecting surrounding tissues and avoiding the severe side effects normally associated with cancer therapy.

Nuvilex believes that incorporating Cell-in-a-Box encapsulation with this type of genetically modified stem cell, along with the proprietary cancer treatment being acquired, could significantly aid and improve patient outcomes.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, We are hopeful for the day when late stage cancers can be routinely and safely treated using genetically modified cells like those used in the pancreatic cancer trial, increasing the ability of clinicians to avoid inducing side effects that typically accompany aggressive chemotherapy and/or radiation. Our cell encapsulation technology will enable practitioners to target tumors while preserving the health of the surrounding tissues. We continue to look for leading stem cell and oncology researchers to partner with us as we bring this technology to market.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

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Nuvilex Points Toward Cell Encapsulation Technology Future to Expand Stem Cell Use for Late Stage Cancer Treatments

By David Fitzpatrick and Drew Griffin, Special Investigations Unit

updated 9:23 PM EST, Thu March 8, 2012

Dr. Zannos Grekos, seen here in 2009, could have his license suspended.

STORY HIGHLIGHTS

(CNN) -- A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

Read more from the original source:
Florida suspends doctor accused of illegal stem cell therapy

By David Fitzpatrick and Drew Griffin, Special Investigations Unit

updated 1:34 PM EST, Thu March 8, 2012

Dr. Zannos Grekos, seen here in 2009, could have his license suspended.

STORY HIGHLIGHTS

(CNN) -- A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy treatment on an elderly patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Dr. Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and allegedly causing the death of an unnamed elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment earlier this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos's activities in 2009 and, at that time, he said he was using stem cell therapy for a company he called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he claimed would help heal crippling diseases, mostly associated with lung problems.

Originally posted here:
Florida suspends doctor accused of illegal stem cell therapy

Lindsay Porter's kidneys weighed 16 pounds before her transplant.

STORY HIGHLIGHTS

(CNN) -- By the time Lindsay Porter had her kidneys removed two years ago, they were bulging -- covered in cysts -- and together weighed 16 pounds.

Her abdominal area was so distended, "I looked nine months pregnant, and people regularly asked when I was due," Porter said.

As she prepared for a transplant to address her polycystic kidney disease, Porter, 47, had mixed feelings -- relief to have found a donor, tinged with resignation. She was looking forward to both a new kidney, and a lifetime on immune system-suppressing drugs.

"You get this brand new shiny kidney, and then they give you drugs that eventually destroy it," said Porter.

But that scenario may eventually change, if results of a new pilot study are replicated in a larger group of patients. The study, published Wednesday in the journal Science Translational Medicine, describes eight kidney transplant patients, including Porter, who received a stem cell therapy that allowed donor and recipient immune cells to coexist in the same body.

The effect, in a handful of those patients, was to trick the recipient's immune system into recognizing the donated kidney as its own.

When it works, patients become a sort of medical rarity called a chimera.

"Chimerism is a condition wherein two different genetic cell populations are present in the body, and both cell types are tolerated," said Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest Baptist Medical Center, who was not involved in the study, via e-mail.

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Transplant without lifetime of drugs?