Stem cell assisted bone repair and artificial liver patents at NJIT receive funding

Treena Arinzeh and Cheul Cho

Two NJIT biomedical researchers have received the prestigious Coulter Foundation Translational Awards for promising patent applications that may one day extend peoples' lives.

The Coulter program provides funding for professors in established biomedical engineering departments in the U.S. The initial amount of funding for each professor will be at least $200,000 over a period of two years.

NJIT Associate Professor Treena Arinzeh will receive funding for her patent application to create an electro-spun composite material for bone repair applications. Her composite material can be combined with stem cells to increase the rate of bone repair.

NJIT Assistant Professor Cheul Cho will receive support for his patent application for an extracorporeal bio-artificial liver assist device with hepatocytes derived from human stem cells for treatment of liver failure. His project aims to differentiate human embryonic stem (ES) cells into functional hepatocytes and to evaluate their therapeutic efficacy in a bio-artificial liver (BAL) for the treatment of acute liver failure. Current potential cell-based therapies and extracorporeal BAL devices for the treatment of liver failure are severely limited by low availability of functional human liver cells, called hepatocytes.

Arinzeh's research focuses on tissue engineering, the application of principles and methods of engineering and life sciences toward a fundamental understanding and development of biological substitutes to restore, maintain and improve the functions of human tissues. Bone regeneration can be achieved through the use of osteogenic cells and/or factors to induce bone growth in combination with an appropriate scaffold to guide and support the establishment of new bone.

Ideally, a scaffold for bone tissue engineering should meet the following minimum requirements, she said. It must be biocompatible, can coexist with living tissues or organisms without causing damage. It must have osteoconductivity capable of serving as a matrix or scaffold in which migrating bone cells can attach and form new bone. It must have minute openings, pores or holes, so the bone can grow inside the material. It should be biodegradable, capable of breaking down within the body without causing damage. Furthermore, it must have mechanical integrity and the ability to withstand chemical, physical, and biological forces.

Cho's research focuses on the design of a clinically scaled bio-artificial liver. About 10 percent of the liver mass is needed to support a patient with acute liver failure, which is a critical limitation for many cell-based therapies for liver failure.

Embryonic stem cells are considered a potential source for cells for hepatic therapies because of their unlimited capacity for self-renewal and proliferation, and their ability to differentiate into all lineages of larger cells.

Cho's novel method differentiates human embryonic stem cells into hepatocytes with high purity. Incorporating these cell derived hepatocytes into a device to treat fulminant hepatic failure has improved test subject survival, demonstrating the potential of the cell therapy. (A provisional patent has also been submitted for this project.)

The Coulter Foundation supports biomedical research that is translational in nature, and it encourages and assists eligible biomedical engineering researchers to establish themselves in academic careers that involve translational research. The translational research projects are directed at promising technologies with the goal of moving toward the commercial development and entering clinical practice.

FDA approves first human embryonic stem cell based clinical trial

Stem cell research and treatment trial can proceed, says the Food and Drug Administration. This week, the Food and Drug Administration granted approval to proceed with the world's first human clinical trial of human embryonic stem cell based therapy. Geron Corp., based in Menlo Park, Calif., says it will proceed with its trial of GRNOPC1, a stem cell therapy to treat patients with acute spinal cord injury, a company statement said Friday.

"We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," Geron President and Chief Executive Officer Thomas B. Okarma said. "Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged -- to achieve restoration of spinal cord function by the injection of … progenitor (stem) cells directly into the lesion site of the patient's injured spinal cord."

"The neurosurgical community is ready to begin the clinical testing of this new approach to treating devastating spinal cord injury," said Richard Fessler, a professor of Neurological Surgery, School of Medicine Northwestern University Feinberg. "If found to be safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."

Resources for finding legitimate stem cell research clinical trials

Scientists are making progress on stem cell research to treat a variety of diseases, but they are warning about clinics pushing unproven treatments.

There are "snake oil" clinics worldwide, warns Sean Morrison, a stem cell expert at the University of Michigan.

The International Society for Stem Cell Research say they are concerned about aggressive marketing of clinical treatments that may not have safeguards to ensure the safety and probable benefit.

In June, the company launched the website closerlookatstemcells.org for people interested in such clinics. The site has already attracted more than 10,000 hits.

The site offers basic information about stem cell research and suggests questions to be asked in a private clinic, such as:

• What is the scientific evidence that this new procedure could work for my illness or condition? Where is this publication?
• Is there any independent oversight or accreditation of the clinic where the treatment will be done and the premises where the cells are processed?
• What are the risks of the procedure and possible side effects, both immediate and long term?

The website also invites readers to submit the names of the clinics, which the company will contact you to obtain specific information, since it creates a public facility. The list will reveal whether these clinics have provided evidence of adequate supervision and protection of the patient.

At the U.S. government site clinicaltrials.gov patients and families can seek treatment from formal studies worldwide that are aimed at specific diseases.