First FDA-Approved Stem Cell Trial to Treat Hearing Loss Begins
A new stem cell study may offer hope for patients suffering from one of the most common causes of child hood deafness.
Sensorineural hearing loss (SNHL) occurs when there is damage to the cochlea or the nerve pathways from the inner ear to the brain. The American Speech-Language Hearing Association says the causes of SNHL can range from genetics and head trauma to drugs, illnesses and more. While most SNHL in children is congenital or acquired after birth, it may present at any age, according to the Website patient.co.uk.
Until recently, SNHL was generally considered a permanent condition. But a new stem cell trial, which launched in January in the United States, could change that thinking.
Children's Memorial Hermann Hospital in Houston, Texas, and the privately owned stem cell bank Cord Blood Registry® (CBR), San Bruno, California, are collaborating on this first FDA-approved, Phase I safety study on the use of cord blood stem cells to treat children with SNHL. The yearlong trial is led by Samer Fakhri, MD, an internationally recognized rhinologist who is currently an associate professor and residency program director at The University of Texas Medical School at Houston.
The researchers are following 10 children, aged 6 weeks to 18 months old, who have sustained post-birth SNHL. Children who are deaf as a result of a genetic anomaly or syndrome are not eligible.
The patients are treated using stem cells from their own stored umbilical cord blood.
“Currently, the only treatment options for sensorineural hearing loss are hearing aids or cochlear implants,” Dr. Fakhri said. “We hope that this study will open avenues to additional treatment options for hearing loss in children.”
“This study is exciting because it might offer a non-surgical option for some children with profound loss,” said co-investigator and auditory-verbal therapist Linda Baumgartner. “More importantly, this is the first treatment with the potential to restore normal hearing.”
The study is supported by CBR and The Institute for Rehabilitation and Research (TIRR) Foundation, a nonprofit organization focused on improving the lives of people who have sustained central nervous system damage through injury or disease.
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Cytomedix Says Acquisition Expands Its Commitment to Regenerative Medicine
Cytomedix Inc. a developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis based in Gaithersburg, Maryland, US, has acquired Aldagen Inc., a privately held biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology. The finalization of the acquisition was announced Feb. 8.
The move is part of Cytomedix's plan to expand from a wound-care based technology platform into a broader regenerative medicine company. Adding Aldagen's patent-protected cell selection technology to the company's product lineup fits well with its existing commercial products and strengthens its long-range growth profile, Cytomedix CEO Martin P. Rosendale said. “In combination, we now touch the three pillars of regenerative medicine with autologous stem cells, platelet-derived signal molecules and plasma scaffolds,” he added.
Aldagen, based in Durham, North Carolina, US, is a clinical-stage biopharmaceutical company developing patent-protected autologous cell-based therapeutics for tissue repair and regeneration. Its initial focus is on developing product candidates to address cardiovascular disease.
According to the company, it has the only stem cell selection technology utilizing an intracellular enzyme marker to fractionate essential regenerative cells from bone marrow.
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China Cracks Down on Unapproved Stem Cell Treatments
China has launched a year-long campaign to rein in unauthorized stem cell clinical trials with an order issued January 10 to stop unapproved stem cell treatments. The Ministry of Health also announced that it would not accept any new applications for stem cell procedures until July, as it attempts to deal with the growing number of unregulated studies and treatments occurring in that nation, many of which are performed on patients from other countries.
CCTV reports that an industry analysis shows that at least 10,000 foreign patients come to China for stem cell treatments each year, and roughly 100 hospitals and clinics are offering the service. Patients are being treated for diseases ranging from cancer and Alzheimer's to spinal cord injuries, blindness and more at a cost of up to tens of thousands of dollars. Many of these are experimental therapies and the patients later say they yielded little or no results.
Ministry spokesperson Deng Haihua said that any stem cell tests already approved by the State Food and Drug Administration would continue. However, health providers could no longer charge money for experimental stem cell applications under the new order, which was jointly issued by China's State Food and Drug Administration (SFDA).
China currently has no policy for clinical trials or applications of stem cell technology. Instead, the trials are subject to general regulations governing all medical practices in that country. Medical experts globally have indicated that they support this latest move by China, but say that a similar 2009 effort had little impact, in part because a number of facilities offering stem cell treatments are run by the military and are not under the governance of the Ministry of Health.
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