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Friday, December 6, 2013

Knee Walker



  This version has an adjustable cushion and handlebars, with dual handbrakes.
Knee scooter in use
A knee scooter or knee walker is a two, three or four-wheeled alternative to crutches or a traditional walker as an ambulation aid. It is known by many other names, such as a knee walker, knee cruiser, knee caddy, orthopaedic scooter, or leg walker.
Over the years it has taken on many forms, from small-wheeled devices suitable for indoor use to larger sturdier units capable of use outside on grass or paved surfaces. Today’s version is usually a lightweight, foldable design that, with the knee flexed, supports the shin of the unusable limb. The opposite foot makes contact with the floor or ground, providing propulsion.
The objective of the scooter is to create a safe, comfortable, and easy-to-maneuver alternative to the traditional crutch. Prior to its introduction, those experiencing foot surgery, bunionectomies, gout, below the knee amputations, diabetic ulcers and wounds, as well as foot sprains, or fractures had no choice but to limit activity during rehabilitation. Their only options were crutches, a traditional walker, a wheelchair or bed rest.
The scooter does have limitations that may make it unsuitable for some patients, such as those with leg injuries above the knee. It cannot negotiate stairs, and is significantly heavier and more difficult to load into a vehicle than crutches.
As knee walkers are often used while the user recovers after surgery, knee walkers are often rented for a short period of time, usually about 4 weeks.
While a Medicare E0118[1] code may have been present in the past for dealers to provide this to patients / beneficiaries, as changes are made to funding, many dealers have the option of renting these products directly for the short use period. Often due to the complexities and costs, many also choose from purchasing this product as a form of cost saving options.

 From Wikipedia, the free encyclopedia


Astrum Healthcare  serves the Houston Metroplex and can deliver you knee walker to your home. Call 281-235-0065 to order your knee walker today.

Click here to visit our webpage







Thursday, February 28, 2013

Competitive bidding: Judge rebukes CMS

 

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Thursday, February 28, 2013
MINNEAPOLIS – A federal judge may have granted the government’s request to dismiss a competitive bidding-related lawsuit filed against CMS by a specialty HME provider, but that doesn’t mean he thinks justice was served.
“This is a sad day for those who believe that when a judge adheres, even-handedly, to his or her oath of office, justice will prevail and the public interest will be served,” U.S. District Judge Donovan Frank wrote in a memorandum.
Shoreview, Minn.-based Key Medical Supply, which provides specialty medical equipment to the developmentally disabled, including customized feeding tubes, argued in a lawsuit filed March 2012 that the competitive bidding program would cripple the company’s business and jeopardize patient access to equipment and supplies.
In the memo, Frank, who presides over the U.S. Court for the District of Minnesota, said he lacked the authority to rule on the legality of competitive bidding, and granted the dismissal on those grounds—albeit with reservations.
“While the decision on the motions is supported by law, the court is deeply concerned about the unjust consequences of its order,” he wrote.
The memo also contained a strong rebuke of competitive bidding and the defendants in the case—CMS and the Department of Health and Human Services (DHHS). Frank wrote that the record indicates a “seeming indifference” on the part of the defendants with respect to those with developmental and intellectual disabilities, whom he said have a demonstrated need for customized feeding tubes because, unlike conventional tubes, they are harder to dislodge.
“Each and every citizen is entitled to equal justice under the law, which is not measured by incidence of death or hospital admissions, but rather by the right to receive medically necessary treatment and to live each day with dignity and respect,” he wrote.
Key Medical is not the only provider to file a competitive bidding-related lawsuit against CMS. The Texas Alliance for Home Care Services (TAHCS) filed a lawsuit against CMS in 2010 that claimed the organization violated federal statutes requiring the agency to disclose the financial standards HME providers must meet under the bidding program. On Feb. 19, the U.S. Supreme Court refused to hear the petition, which would have stopped CMS from awarding competitive bidding contracts. The high court upheld a D.C. Court of Appeals ruling that DME statutory provisions precluded the appeals court from reviewing the issue.

This article is from HME NEws published 0n 2/28/2013

Wednesday, October 24, 2012

Manuals: Coding decisions cause complications

 By Elizabeth Deprey
 HME News

 
Friday, October 19, 2012

ATLANTA – Two recent coding decisions by the PDAC that involve manual wheelchairs are putting patient access at risk, says Rita Hostak, vice president of government relations for Sunrise Medical.
“These decisions are not benign,” she said during a complex rehab update at Medtrade Oct. 18. “They have a very significant impact on the industry and the people who need this equipment.”
The more troubling of the two coding decisions: K0009, a miscellaneous custom ultralight wheelchair, will soon be categorized under the manual wheelchair HCPC code. Manufacturers have until March to resubmit K0009 coding verification applications to the PDAC while the contractor works to revise the code.
“They don’t like miscellaneous codes,” said Hostak. “Their intention is to move this into the existing (manual wheelchair) HCPC code.”
This will create access problems because K0009 would become a capped-rental item and providers would have no way to bill for the wheelchair’s tilt feature. Also, it would clear the way for K0009 to be included in competitive bidding, Hostak said.
“I don’t know that they understand the potential impact,” she said.
The other coding decision putting patients in jeopardy: A requirement announced this summer that E1161 manual wheelchairs be provided with wheels large enough and positioned to self-propel. Users in these wheelchairs generally don’t self-propel and the decision about whether the wheelchairs should have larger wheels should be made on an individual basis , Hostak said.
“They’re confused about the population that uses this chair,” she said. “There are reasons why you wouldn’t choose those wheels for these patients, like safety. We want to keep people’s hands out of the way.”
NCART has reached out to the PDAC and the medical directors to let them know the consequences of these decisions. It believes the PDAC should consult manufacturers and providers about potential impacts before making coding decisions like these, says Don Clayback, executive director.
"The consequences can be significant," he said. "And decisions like these trickle down to other payers."


This article originally appeared in HME News on Friday OCtober 19th, 2012

 J & R Medical is happy to assist you with all of your wheelchair, medical supply or urological needs.
713-344-0901

Thursday, September 20, 2012

New drug shows promise in multiple sclerosis treatment, researchers say

(CBS News) There's a new treatment for multiple sclerosis, or MS, which affects more than 400,000 Americans.
MS can strike anyone at any time, but it usually hits adults in the prime of their lives. But researchers say a new drug is proving very promising.
FDA approves new multiple sclerosis treatment Aubagio
As an electrician, 49-year-old Stephen O'Malley depends on good vision. But seven years ago, things suddenly began to go dark.
O'Malley recalled, "I was scared to death. I went to work at 6:00 in the evening and I was completely blind in one eye six hours later."
The Cleveland father of two was diagnosed with MS. MS is a neurological disease that affects the brain and spinal cord. Symptoms can range from numbness and tingling to blindness and paralysis. They usually get worse over time, leaving many patients greatly disabled.
While there is no cure for MS, there are effective treatments. Kate Lodge gets monthly infusions requiring a two-hour visit to the hospital, but there are scary potential side effects, including fatal brain infections.
"The symptoms of the brain infection can mirror the symptoms of MS, so you can't know," Lodge said. "And so you go into a panic mode."
Dr. Robert Fox is medical director at the Cleveland Clinic's Mellen Center for Multiple Sclerosis. He said what was needed in an MS treatment is a combination of effective therapy that's well tolerated and safe.
And now, that therapy may finally be here in an easy-to-take pill form.
Fox led clinical trials of a new drug, called BG-12, which seems to help prevent flare-ups of MS. The research, published in the New England Journal of Medicine, involved more than 2,000 patients from all over the world who were followed for two years. Patients on BG-12 had about a 50 percent reduction in relapses compared to placebo and a 70 percent reduction in brain scarring on MRIs.
"We don't have a cure yet," Fox said, "but we have gotten that much closer to getting good control of this disease."
As for O'Malley, he has not had a single MS episode since going on the drug. Some of his vision has returned, and he feeling optimistic about the future.
"You have to characterize it as a miracle," he said. "I feel healthier than I felt seven years ago when I got diagnosed."
Researchers hope BG-12 will quickly gain the U.S. Food and Drug Administration's approval.
Watch Dr. Jonathan LaPook's full report in the video above.
© 2012 CBS Interactive Inc.. All Rights Reserved.

Monday, September 17, 2012

What's an RTS?


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Friday, September 14, 2012

WASHINGTON – CMS created confusion over acronyms in August when it sent out bulletins about its decision to designate K0005 as complex rehab.
In the bulletins, the agency made references to requiring an assistive technology professional (ATP) to provide the wheelchair, but it also made references to a rehab technology supplier (RTS). In the industry’s view, they are not one in the same.
"RTS describes a person's function," said Simon Margolis, executive director of NRRTS. "It's what everybody does. An ATP is an RTS who takes the test and gets certified as an ATP."
Medicare's apparent use of the terms ATP and RTS interchangeably could cause confusion down the road, stakeholders fear.
CMS clarified its stance in an MLN Matters article on Sept. 11, stating "A qualified RTS is an individual that has one of the following credentials: Certified Rehabilitative Technology Supplier (CRTS); Assistive Technology Supplier (ATS) (discontinued 12/31/2008); Assistive Technology Practitioner (ATP) (discontinued 12/31/2008); Assistive Technology Professional (ATP) (effective 1/1/2009).”
So even though stakeholders and CMS may view the term RTS differently, it appears they’re on the same page about what’s required to provide a K0005 wheelchair.
"When you read the whole thing, it's clear," said Peggy Walker, a billing and reimbursement adviser for U.S. Rehab. "You're all set as long as you have an ATP or CRTS."
The MLN Matters article is available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1233.pdf.

This article is from www.hmenews.com

 

Wednesday, September 5, 2012

This article hosted by:  Patrick Boardman

 Power Wheelchair Brings Independence and Hope to Man with Complications Due to Spina Bifida

PR Newswire

Mobility Matters Bulletin from the American Association for Homecare
LOUISVILLE, Ky., Aug. 9, 2012 /PRNewswire-USNewswire/ -- Like many others with spina bifida, Ryan Wilson has lived much of his life with medical challenges that have affected his mobility. Five years ago, after Wilson developed a decubitus ulcer his mobility became severely restricted.
"My body was just not the same as far as mobility," said Wilson, 35. "I was a walking person who became a wheelchair person."  After nearly five years with a manual wheelchair, Wilson said his body was worn down, his shoulder too weak to maneuver the chair. He had to move in with his mother.
But Wilson said the downward spiral spun upward in February when Medicare approved him for a power wheelchair, a medical device that lifted his spirits and changed his life.
"My shoulders have just about given out and the power chair has brought me back into society," Wilson said. "Especially after the ulcer, I was basically bedridden and couldn't get around my own house.  If I wanted to go out someone would have to push me because my shoulders quit.  With the power chair, the shoulders are not an issue.  I can go until the battery quits."
Once Wilson developed the ulcer, he stopped working. His doctor said he could have died from an infection.  Now, however, Wilson said the power wheelchair has returned some of the independence that he had missed, including grooming, preparing food, and getting to the bathroom. "And being able to leave my house, go up and down the street on the sidewalk, walk the dog, and go outside and spit in the yard," Wilson said. "Just simple things that I would need help with, now I don't."
Wilson is like thousands of Medicare patients across the country: they depend on power wheelchairs to allow them to live safely and independently at their homes.  For many people living with disabilities, the power wheelchair is what prevents them from being confined to a nursing home or other care facility.  Studies show that power wheelchairs actually reduce government health spending because Medicare patients have fewer falls and hospital emergency room visits with power wheelchairs. The mobility devices also delay placement in costly care facilities.
Yet, over the last nine years, the Centers for Medicare & Medicaid Services (CMS) has repeatedly implemented a series of policy and regulation changes making it more difficult for Medicare beneficiaries to receive power wheelchairs prescribed by their physicians.  At the same time, home medical equipment providers have faced devastating cuts in reimbursements for power wheelchairs, excessive audits, and other policies that jeopardize their ability to continue providing the medical devices.
"Senior citizens and people living with physical disabilities clearly benefit from power wheelchairs, but CMS and Congress repeatedly adopt policies that restrict use of the Medicare power mobility benefit," said Tyler Wilson, (no relation to Ryan), who is president and CEO of the American Association for Homecare. "This increases government spending by driving Medicare patients into expensive nursing homes and other care facilities.  The government has to get smarter about health care policy."
The latest threat to the benefit comes from CMS' plan to implement a demonstration program that will subject all claims for power mobility to a prior authorization process for a period of three years in California, Florida, Illinois, Michigan, New York, North Carolina and Texas.  Medicare patients in these states receive nearly 50 percent of the power mobility prescribed annually to beneficiaries.
While stakeholders, such as physicians, providers and disability advocates, generally support the prior authorization program, most steadfastly insist that it include a clinical template that physicians can use to precisely provide the information that CMS seeks to document patients' medical need for power wheelchairs. The current documentation guidelines are so subjective and flawed that CMS contractors routinely deny claims for power wheelchairs that were prescribed by physicians. Many denied claims are overturned after lengthy and costly appeals, but under the prior authorization program Medicare patients would not obtain a power wheelchair until after the denials are resolved and some beneficiaries may never be approved for the equipment.
This has prompted sharp criticism from consumer advocates, such as the Association of Programs for Rural Independent Living (APRIL).  "We remain concerned that the program CMS has designed…has the potential to eliminate the Medicare benefit for power mobility devices for individuals who reside in one of the seven States where the program will be implemented," Billy Altom, the APRIL executive director, warned in a recent letter to CMS.
Meanwhile, Ryan Wilson doesn't understand why CMS and Congress are adopting policies that restrict utilization of the Medicare power mobility benefit.
"My power wheelchair means so much to me," said Wilson. "Although it is not feasible, I would love for some lawmakers and bureaucrats to spend time in wheelchairs to help them realize just how hard it is…that's the type of experience that would help them understand why people need them and why advocates for people who are disabled fight so hard that we can have access to them."
The American Association for Homecare represents durable medical equipment providers and manufacturers who serve the medical needs of millions of Americans who require oxygen equipment and therapy, mobility devices, medical supplies, inhalation drug therapy, and other medical equipment and services in their homes. Members operate more than 3,000 homecare locations in all 50 states.  Please visit www.aahomecare.org/athome.

SOURCE American Association for Homecare
 

Monday, November 8, 2010

Fix Medicare’s Bizarre Auction Program

September 30, 2010, 2:30 pm Fix Medicare’s Bizarre Auction Program
By IAN AYRES


Here’s a piece co-authored with auction guru Peter Cramton, a professor of economics at the University of Maryland:

By Ian Ayres and Peter Cramton

Harry Truman once quipped, “Give me a one-handed economist! All my economists say, ‘On the one hand, on the other’” Often even a lone economist has difficulty making a recommendation. While true on certain matters, there are many issues where economists do agree about the right and wrong course of action. A case in point is competitive bidding for Medicare supplies.

Economists and other auction experts agree that using administrative prices from 25 years ago to set Medicare prices is a bad idea, and that a much better approach is to price Medicare supplies in competitive auctions. That is not surprising. What is surprising is the degree of consensus that Medicare’s shift to auctions is fatally flawed and must be fixed for the Medicare auctions to succeed in lowering costs while maintaining quality for medical equipment and supplies.
For the last ten years, the Centers for Medicare and Medicaid Services has been testing an auction approach that is incredible in the inefficiency of its flawed design. This policy brief lays out a number of weaknesses with the auction procedure but it is sufficient to focus on the interaction of just two:

Bids are not binding commitments
In the Medicare auction bidders are not bound by their bids. Any auction winner can decline to sign a supply contract following the auction. This undermines the credibility of bids and encourages low-ball bids in which the supplier acquires at no cost the option to sign a supply contract. This aspect of the current system has led to the predictable outcome where a number of bidders, realizing that prices were set below their costs, have refused to sign contracts.

Flawed median-bid pricing rule
As is standard in multi-unit procurement auctions, bids are sorted from lowest to highest, and winners are selected, lowest bid first, until the cumulative supply quantity equals the estimated demand. Non-standard is that the current system sets reimbursement prices using the median of the winning bids rather than using the clearing price. Since most providers are small, they lack the resources to invest in information and strategy in preparing bids. For them an effective and easy strategy is the low-ball bid, as any one firm’s impact on price is negligible. The low-ball bid is appealing to these firms because it is a winning bid with a negligible effect on the price. However, with many firms following this strategy the median-bid price is significantly biased downward and possibly below the cost of all suppliers. This possibility is not a problem for the low-ball bidders since, as described above, suppliers have the option of not signing the contract in such an event. Equally troubling is that fifty-percent of the winning bidders are offered a contract price less than their bids.(emphasis added)

There are good reasons why we have never seen a median pricing rule combined with withdrawable bidding. It is not likely to elicit serious signals of value. You can read more about the auction rules, the relevant portion of the Federal Register explaining the final rules, a journal article showing some of the problems, and the official bidding form, eligibility requirements, and quality standards).

One of us recently asked a group of auction experts (mostly prominent economists but also computer scientists and engineers) to be signatories of a letter to Chairman Stark, House Ways and Means Health Subcommittee, advocating the use of auctions to price Medicare supplies, but sharply criticizing the government’s proposed auction approach, which the administering agency (the Centers for Medicare and Medicaid Services) has been testing for the last ten years in several metropolitan areas. In less than 48 hours, 167 experts signed the letter—including multiple Nobel prize winners and members of the National Academy of Sciences.

Medicare should junk the flawed procurement auction rules and take advantage of the enormous advances that have been made in auctions and market design to fix the auction rules. “The appropriate bidding mechanism would arise from a collaboration of government officials, industry representatives, and auction experts,” wrote Peter and Brett Katzman in the policy brief mentioned above. “It would emphasize transparency, good price and assignment discovery, and strategic simplicity. The result would be sustainable long-term competition among suppliers that reduces costs while maintaining high quality.” This approach has been used with great success in other complex settings such as government auctions of radio spectrum and modern electricity markets. The engagement of auction experts should not be surprising. The economic problems being solved are far from trivial. The government would never consider building a bridge without the input of bridge experts on its design. Similarly, the government should enlist the help of expert auction designers when structuring complex auction markets. (In full disclosure, we have provided paid advice to government and non-governmental entities on how best to structure auctions.)

The mystery is why the government has failed over a period of more than ten years to engage auction experts in the design and testing of the Medicare auctions. The letter confirms that any expert would be able to quickly identify fatal flaws in the Medicare competitive bidding program. We suspect the problem is that CMS initially did not realize that auction expertise was required, and once they spent millions of dollars developing the failed approach, they stuck with it rather than admit that mistakes were made. This bureaucratic inertia is seen not just in government but in all organizational decision making.


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Ian Ayres is a professor of law and economics at Yale. Follow @freakonomics on Twitter.

Thursday, October 28, 2010

Indiana (doesn't) want me? Parents of disabled may wonder

This article, written by Ken Kusmer, appeared in the Oct. 28, 2010 edition of Indystar.com, the Indianapolis Star's online edition.


Indiana's budget crunch has become so severe that some state workers have suggested leaving severely disabled people at homeless shelters if they can't be cared for at home, parents and advocates said.


They said workers at Indiana's Bureau of Developmental Disabilities Services have told parents that's one option they have when families can no longer care for children at home and haven't received Medicaid waivers that pay for services that support disabled people living independently.


Marcus Barlow, a spokesman for the Family and Social Services Administration, the umbrella agency that includes the bureau, said suggesting homeless shelters is not the agency's policy and workers who did so would be disciplined.


However, Becky Holladay of Battle Ground, Ind., said that's exactly what happened to her when she called to ask about the waiver she's seeking for her 22-year-old son, Cameron Dunn, who has epilepsy, autism and attention deficit hyperactivity disorder.


Holladay, a school nurse, said she and her husband would go bankrupt trying to pay for services themselves, so Cameron spends most days sitting in his stepfather's truck while he works as a municipal employee.


"It's heart-wrenching as a parent to watch it. We are people and they are people," Holladay said, referring to her son and others with disabilities. "They have lives that are worth something."


There have been no confirmed cases of families dumping severely disabled people at homeless shelters because Indiana wouldn't provide the care needed.


But some families have been on waiting lists for waivers for 10 years. The lists contained more than 20,000 names last month, and one advocacy group predicted they will only grow longer because Gov. Mitch Daniels ordered budget cuts that have eliminated 2,000 waiver slots since July.


Budget cuts also have resulted in the state moving foster children with disabilities to a lower cost program that doesn't provide services for special needs and eliminating a grocery benefit for hundreds of developmentally disabled adults.


Kim Dodson, associate executive director of The Arc of Indiana, said her group has received reports of state workers in several of BDDS's eight regional offices telling families to take disabled adults to homeless shelters. She speculated that the suggestion resulted from frustration among BDDS staff as families become more outspoken about the effects of state cuts.


"It is something we are hearing from all over the state, that families are being told this is an alternative for them," Dodson said. "A homeless shelter would never be able to serve these people."


State lawmakers said they also have received reports from several people who were told they could always abandon their adult children at homeless shelters.


Rep. Suzanne Crouch, R-Evansville, said she found it "deplorable that people are being told to go to a homeless shelter."


Leaders of several agencies serving homeless people across Indiana could not be reached for comment after business hours Wednesday.


Some parents said homeless shelters have also been suggested -- or threatened -- as an option by private care providers.


Daunna Minnich of Bloomington said Indiana Department of Education funding for residential treatment for her 18-year-old daughter, Sabrina, is due to run out Sunday. She said officials at Damar Services Inc. of Indianapolis told her during a meeting that unless she took Sabrina home with her, the agency would drop the teen off at a homeless shelter.


Sabrina, who's bipolar and has anxiety attacks, has attempted suicide, run away during home visits and threatened her older sister, Minnich said. Bringing Sabrina home isn't a viable option, but the two group home placements BDDS offered weren't appropriate, she said.


"I don't want to see the state of Indiana hasten her demise by putting her in a one-size-fits-all solution that will drive her to desperate acts," Minnich said.


Jim Dalton, Damar's chief operating officer, said he could not comment directly on any specific case but his nonprofit would never leave a client at a homeless shelter -- even though it is caring for some for free after they got too old for school-funded services and haven't yet been granted Medicaid waivers.


"We're talking about youth that absolutely require services, and no one is willing to fund them anymore," Dalton said.

Saturday, October 16, 2010

Researchers reportedly regenerate adult spinal cord tissue

The following originally appeared in Action Online, the magazine of the United Spinal Association.

Researchers for the first time have induced robust regeneration of nerve tissue connections in injured adult spinal cord sites that control voluntary movement. These findings provide hope that it may be possible to design therapies for paralysis and other impairments of motor function arising from spinal cord injury.

In rodent studies, the Children’s Hospital Boston, UC Irvine, and UC San Diego team made this breakthrough by turning back the developmental clock in a molecular pathway critical for the growth of nerves in the corticospinal tract. The corticospinal tract is a bundle of nerves connecting the brain and spinal cord. While some degree of nerve regeneration has been achieved in other regions of the mature central nervous system (CNS), adult corticospinal nerves have been particularly resistant to regeneration after injury.

The corticospinal nerve regeneration was achieved by deleting PTEN, an enzyme that acts as a critical brake on cell growth. One of the key growth molecules whose activity can be reined in by PTEN is mTOR. In early stages of life, PTEN activity is low, allowing mTOR to promote developmental growth processes. In later stages, PTEN activity is increased and mTOR activity is decreased so that growth is more restricted.

In looking at how to restore early developmental-stage cell growth in injured CNS tissue, Zhigang He, a neurology associate professor at Children’s Hospital Boston–working with Mustafa Sahin, also of the Children’s Neurology Department–showed in a 2008 study that modulating the PTEN/mTOR pathway enabled regeneration of new connections from the eye to the brain after optic nerve damage. He is now partnered with Oswald Stewart from UCI and Binhai Zheng of UCSD to use the same approach to induce nerve regeneration in injured spinal cord sites. Results of their study appear in the Aug. 8 online edition of Nature Neuroscience.

“Until now, such nerve regeneration has been impossible in the spinal cord,” says Oswald Steward, anatomy & neurobiology professor and director of the Reeve-Irvine Research Center at UCI. “Paralysis and loss of function from spinal cord injury has been considered untreatable, but our discovery points the way toward a pathway to develop a therapy to induce regeneration of nerve connections following spinal cord injury in people.”

Clinical Trial of Human Embryonic Stem Cell-Based Therapy Now Under Way

On Oct. 11, 2010, Geron Corporation announced the enrollment of the first patient in the company’s clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1. The primary objective of this Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, Ga. Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial.

“Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “When we started working with hESCs in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials. This accomplishment results from extensive research and development and a succession of inventive steps to enable production of cGMP master cell banks, scalable manufacture of differentiated cell product, and preclinical studies in vitro and in animal models of spinal cord injury, leading to concurrence by the FDA to initiate the clinical trial.”

“We are pleased to have our patients participating in this exciting research,” said Donald Peck Leslie, M.D., medical director, Shepherd Center. “Our medical staff will evaluate the patients’ progress as part of this study. We look forward to participating in clinical trials that may help people with spinal cord injury.”

David Apple, M.D., Shepherd Center’s medical director emeritus and principal investigator of the trial at Shepherd Center, said, “This clinical trial represents another step forward in Shepherd Center’s involvement in an attempt to find a cure for paralysis in people with spinal cord injury. Shepherd Center is an ideal place to conduct this study because of our clinical expertise and the volume of patients referred here for rehabilitation care.”

In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is also open for patient enrollment. As additional trial sites come online and are ready to enroll patients, they will be listed on the Patient Information pages of Geron’s website and on the NIH clinical trials registry,ClinicalTrials.gov.

Further information on the criteria for patient eligibility for the study is also available on ClinicalTrials.gov.