NASA scientists were looking for ways to sustain astronauts for long periods of space flight when they discovered that human cells and tissues could be grown rapidly in the weightless environment in space. That discovery led to the invention of technology designed to simulate that environment for the growth and expansion of adult stem cells.

It was a case of "serendipity coupled with brilliance," said David Bonner, CEO of Houston-based Regenetech Inc., a company founded in 2002 to exclusively license a portion of that NASA technology for adult stem cell uses.

"It's not surprising that NASA's behind this," he said, adding that the agency's technology division was one of the major drivers of the microelectronics explosions, as engineers focused on designing computers small enough for shuttles. "I think, in retrospect, that NASA may also be credited with the first practical application of adult stem cells."

Research at the space agency dates back to the 1980s, and began as efforts to address the toll that long-term space travel takes on the human body. Along with water loss, astronauts also risk losing calcium in bones and other nutrients, and NASA recognized early on that new advancements would be needed for prolonged flights, Bonner said.

Astronaut David Wolf, a scientific advisor for Regenetech, who has clocked more than 150 days in space, including 128 days aboard the MIR space station, was instrumental in developing technology designed to "offset and prevent" the physical effects of space travel, specifically in the areas of bone, cartilage and tissue growth, Bonner said.

The technology involves placing cells in a rotating bioreactor, a machine that simulates the weightless environment of space. Regenetech "built on that technology and took it into a different direction," he told BioWorld Today.

The company began working with hematopoietic stem cells and created the CellXpansion technology to expand those stem cells. The company uses a rotating bioreactor licensed from Houston-based Synthecon Inc. combined with a magnetic field system used to enhance the growth rate. The goal is to "reproduce therapeutic stem cells," Bonner said, for treatments that could have "widespread use in diseases such as diabetes, heart and stroke."

A number of companies are working in the adult stem cell space, and with few exceptions, most are relying on stem cells harvested from patients' bone marrow to be grown and implanted on an autologous basis. While there's been some success on that front, the bone marrow harvesting can be a painful and expensive procedure, Bonner said. In contrast, Regenetech's method "eliminates the use for bone marrow and, instead, harvests stems cells from blood."

About 0.1 percent of peripheral blood cells are stem cells, but Regenetech's technology, called the cellXpansion system, can take that small number of stem cells and grow them to therapeutic capabilities "in a matter of days," for autologous implantation into damaged tissue, Bonner said.

The company was granted its first patent only a short time ago and has pending applications for at least 90 more.

"So we're at the stage now where we have our own facilities, and we're reducing the technology to practical, usable and commercial form," he said.

To date, Regenetech has raised about $4 million in seed and angel funding. But Bonner said the firm does not intend to operate using the traditional model for biotech start-ups. Instead of seeking large venture capital funding rounds, Regenetech aims to build an early revenue stream to support further development. The company "identified areas that do not require human clinical trials," Bonner said, and will thereby sidestep the early costs and time requirements of the regulatory process.

To start with, Regenetech is allowing licenses to stem cell banks for the use of its cellXpansion technology to expand hematopoietic stem cells for autologous use. Second, the company will venture into veterinary orthopedics, a market estimated at about $10 billion annually, which involves no FDA regulation. In that area, the company offers its magnetic field system, which has shown "remarkable results in rats" in promoting bone and cartilage growth, Bonner said. "We have trials in progress now and those early results are promising."

Regenetech also is in "early conversations" with companies focused on human orthopedics that could use its stem cell expansion process to grow and expand mesenchymal stem cells for bone, tendon and cartilage repair.

In the future, Bonner sees moving into clinical trials "in select areas or with partners." But for now, the company of seven employees focuses on building revenue, and continuing research under sponsored research agreements with universities, such as work with Texas A&M University in orthopedic indications and with the University of Texas Medical Branch in Galveston on umbilical cord stem cell research.

No Comments