Mesoblast's NeoFuse Stem Cell Product Shows Positive Results in Phase 2 Lumbar Spinal Fusion Trial

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MELBOURNE, Australia, Jan. 11, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX:MSB) (MBLTY) today announced that its Phase 2 clinical trial for lumbar spinal fusion had successfully met its safety and efficacy endpoints.

The results suggest that Mesoblast's NeoFuse product comprising allogeneic Mesenchymal Precursor Cells (MPCs) is as effective for interbody lumbar fusion as the gold standard, bone autograft, without the need for a second surgical procedure and its attendant morbidity risks. These results support the progression of clinical development of NeoFuse to a Phase 3 trial in interbody lumbar fusion.

The results were highlighted during a presentation to the 31 st annual JP Morgan Healthcare Conference in San Francisco by Mesoblast Chief Executive Professor Silviu Itescu.

Twenty four (24) patients were enrolled and randomized over 5 sites in the United States with 8 patients in each treatment arm -- bone autograft standard of care (Control), 25 million MPCs (25M), and 75 million MPCs (75M). Patients underwent the surgical procedure, one or two level fusions using a posterior approach to the spine, and were evaluated for safety and efficacy. The median follow-up times for the three treatment groups were 23.9, 20.7, and 22.9 months for the bone autograft, 25M, and 75M groups, respectively.

MPCs were well tolerated with no cell-related serious adverse events and no ectopic bone formation at all. Notably, MPC treated groups had 30-43% lower mean estimated blood loss during surgery compared to the autograft treatment group (p less than 0.05 for the 25M group).

At 12 months, fusion was achieved in 85.7% of patients in the 25M treatment group compared to 62.5% in the 75M and 75% in the control patient groups. Overall, patients from all three treatment groups had a clinically significant and comparable decrease in low back and leg pain, assessed on the Visual Analogue Scale and functional improvement, assessed by the Oswestry Disability Index questionnaire.

Dr Randall Dryer, an orthopedic surgeon with the Central Texas Spine Institute and an investigator in Mesoblast's study, said: "For patients whose spinal discs have degenerated too extensively for repair, bony fusion of adjacent vertebra is the primary option to eliminate chronic and debilitating pain.

"Other than autograft, there is no approved product for posterior spinal fusion, a surgical approach which accounts for 62% of all lumbar fusion procedures. There is a critical unmet need for new technologies to achieve fusion that are safe, effective, and that eliminate the need for bone autograft.

"Based upon my experience in the Phase 2 study, Mesoblast's cells may provide a significant and valuable option to achieve fusion in patients with severe spinal disc degeneration and these results warrant progressing to a Phase 3 study," Dr Dryer added.

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Mesoblast's NeoFuse Stem Cell Product Shows Positive Results in Phase 2 Lumbar Spinal Fusion Trial

Stem cell treatment for spine tested

AN Australian-invented stem cell treatment for spinal surgery has been successfully used for the first time in the United States.

The patented stem cells product created by Melbourne-based company Mesoblast was trialled in a small group of patients with spinal discs that had degenerated beyond repair.

The bone marrow-derived stem cells - called mesenchymal precursor cells (MPCs) - were used to promote bone growth to fuse together spinal vertebrae, to eliminate debilitating leg and back pain.

If the procedure ultimately passes the final stage of clinical trials and is approved by America's drug regulator, it would potentially provide patients worldwide with a quicker and less invasive procedure.

The Food and Drug Administration (FDA)-approved trial compared the use of stem cells to fuse vertebrae with bone harvested from the patient's own hip, the current gold standard for this common operation.

The stem cells were used in conjunction with two chemicals to encourage bone growth, said Texas surgeon Dr Randall Dryer, who performed a number of surgical procedures in the trial.

The chemicals, hydroxyapatite and tricalcium phosphate, are non-cellular components of bone that tell the stem cells to turn into bone-forming cells, rather than other tissues, Dr Dryer said.

"If you put these cells into an environment that stimulates them to grow into bone, they do," Dr Dryer told AAP.

"That eliminates us having to take the patient's own bone from a different location to pack in there."

Dr Dryer, an orthopedic surgeon at the Central Texas Institute in Austin, said eight of the 24 patients enrolled in the trial had the surgery using their own bone.

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Stem cell treatment for spine tested

DOH: Stem cell therapy dangerous

By JENNY F. MANONGDO

Manila, Philippines Doctors yesterday warned against fatal complications of the use of stem cell therapy.

According to the Philippine Society for Stem Cell Medicine (PSSCM), a stem cell transplant poses a host of complications, including fatal complications that depend on several factors such as the type of blood disorder, type of transplant and the age and health of the person receiving the transplant. If the stem cell that you received is not from your own body, it could lead to fatal complications, PSSCM said.

The Philippine Medical Association (PMA) also warned that a patients body may reject the transplant stem cells from a donor.

Although some people experience few problems with a transplant, others may develop complications that may require treatment or hospitalization. Some complications could even be life-threatening, said Dr. Leo Olarte, PMA vice-president.

According to Olarte, the complications that can arise with a stem cell transplant include graftversus-host disease, stem cell (graft) failure, organ injury, infections, cataracts, infertility, new cancers, and even death.

According to Olarte, a person who will undergo a stem cell transplant from a donor (allogeneic stem cell transplant) may be at risk of graft-versus-host disease.

This condition occurs when a donors transplanted stem cells attack your body. Graft-versushost disease can be mild or severe. It can occur soon after your transplant or months to years later. Aside from the graft-versushost disease, stem cell transplant from a donor can likewise affect any organ, commonly the skin (rash, often like sunburn), gut (mouth sores, abdominal pain, diarrhea, nausea or vomiting), liver (jaundice or yellowing of the skin), lungs (blocked airways) or eyes (irritation and light sensitivity).

Olarte said it could also lead to chronic disability arising from organ injury or infections that are potentially life-threatening.

Commercial establishments offering stem cell treatments have increased following its popularity in the treatment of various diseases.

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DOH: Stem cell therapy dangerous

Stem cell could lead to complications, death

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Stem cell could lead to complications, death

Doctors Warn Against Fatal Stem Cell Complications

MANILA Philippines --- Doctors yesterday warned against the fatal complications of the use of stem cell therapy.

According to the Philippine Society for Stem Cell Medicine (PSSCM), a stem cell transplant poses a host of complications, including fatal complications that depend on several factors such as the type of blood disorder, type of transplant, and the age and health of the person receiving the transplant.

"If the stem cell that you received is not from your own body, it could lead to fatal complications," PSSCM said.

The Philippine Medical Association (PMA) also warned that a patient's body may reject the transplant stem cells from a donor.

"Although some people experience few problems with a transplant, others may develop complications that may require treatment or hospitalization. Some complications could even be life-threatening," Dr. Leo Olarte, PMA vice president said.

According to Olarte, the complications that can arise from a stem cell transplant include graft-versus-host disease, stem cell (graft) failure, organ injury, infections, cataracts, infertility, new cancers, and even death.

According to Olarte, a person who will undergo a stem cell transplant from a donor (allogeneic stem cell transplant) may be at risk of graft-versus-host disease.

"This condition occurs when a donor's transplanted stem cells attack your body. Graft-versus-host disease can be mild or severe. It can occur soon after your transplant or months to years later. Aside from the graft-versus-host disease, stem cell transplant from a donor can likewise affect any organ, commonly the skin (rash, often like sunburn), gut (mouth sores, abdominal pain, diarrhea, nausea or vomiting), liver (jaundice or yellowing of the skin), lungs (blocked airways) or eyes (irritation and light sensitivity)."

Olarte said it could also lead to chronic disability arising from organ injury or infections that are potentially life-threatening.

Commercial establishments offering stem cell treatments have increased following its popularity in the treatment of various diseases.

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Doctors Warn Against Fatal Stem Cell Complications

Malaya Business News Online – Philippine Business News | Online News Philippines

Details Published on Wednesday, 09 January 2013 23:00 Written by GERARD NAVAL

The Philippine Society for Stem Cell Medicine (PSSCM) yesterday warned the public that stem cell treatment, an emerging medical procedure, poses risks that could be fatal.

Dr. Leo Olarte, PSSCM spokesman, said stem cell treatment has been found to carry a whole range of risky complications with some being fatal.

He said these include graft-versus-host disease (allogeneic transplant only), stem cell (graft) failure, organ injury, infections, cataracts, infertility, new cancers, and death.

In particular, Olarte explained that the graft-versus-host disease can occur soon immediately after the transplant or months to years later.

This condition occurs when a donors transplanted stem cells attack your body, said Olarte.

He said it may arise from factors such as the type of blood disorder, the type of transplant, and the age and health of the person.

Olarte also noted that graft-versus-host disease can affect any organ, but is commonly seen in the skin (rash, often like sunburn), gut (mouth sores, abdominal pain, diarrhea, nausea or vomiting), liver (jaundice or yellowing of the skin), lungs (blocked airways) or eyes (irritation and light sensitivity).

Last October, the Department of Health (DOH) issued an advisory saying stem cell therapy is a procedure that is not yet an adopted standard way of treatment and remains under clinical evaluation.

Stem cell therapy is a type of intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury.

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Malaya Business News Online - Philippine Business News | Online News Philippines

Forward for Stem Cell Funding

The US Supreme Court has declined to review Sherley v. Sebelius US Court of Appeals ruling, ending the legal effort to block federally funded research on human embryonic stem cells, reports ScienceInsider.

National Institutes of Health Director Francis Collins says he was "very pleased" with the decision. "[It] allows the ruling to stand, and enables NIH to continue conducting and funding stem cell research, following the strict ethical guidelines put in place in 2009," he says in a statement. "Patients and their families who look forward to new therapies to replace cells lost by disease or injury, or who may benefit from new drugs identified by screening using stem cells, should be reassured that NIH will continue supporting this promising research."

The suit was brought by James Sherley and Theresa Deishe, both adult stem cell researchers, after the Obama administration issued an executive order in 2009 expanding the human stem cell lines that are eligible for federal funding. Sherley and Deishe argued that NIH violated the Dickey-Wicker amendment that bars it from funding research that destroys embryos, Donald Zuhn at Patent Docs adds.

They received a preliminary injunction in 2010, but that was then vacated by the US Court of Appeals for the District of Columbia Circuit, Zuhn says. The Supreme Court then denied their petition for appeal.

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Forward for Stem Cell Funding