Every war spikes a great leap forward in medicine. With World War I came antibiotics. World War II saw the achievement of effective surgery. Vietnam brought us infinitely improved ways to handle trauma. “For this generation, the great medical contribution will undoubtedly be recognized as cell and bio-regeneration,” says Elizabeth Sump, Cleveland Clinic’s executive director of the Clinical Tissue Engineering Center.
Truly, the very concept of regrowing living tissue to replace a diseased part seems so new and drastic as to float in the realms of Star Trek. But the annual New Jersey Symposium on Biomaterials Science and Regenerative Medicine shows just how much this generation the processes are.
Sump will chair one of many sessions during the three-day symposium, held Wednesday through Friday, October 29 through 31. Each day begins at 8 a.m. at the Hyatt Regency in New Brunswick. Cost: $825. Visit www.njbiomaterials.org/symposium.
Nationwide experts are gathering to discuss such topics as “Disruptive Technologies for Treating Compartment and Brain Injuries,” chaired by Joseph Rosen; “Reconstruction and Regeneration of Musculoskeletal Tissue,” chaired by George Muschler, and the Rutgers prime project, “Combinatorial-Computational Method for Biomaterials Optimization” chaired by Pallassana Narayanan.
From the businessperson’s perspective, Sump’s workshop discussing the “Barriers to Biomaterials Development” might feel most familiar. Having spent the last 20 years in both the research and the commercialization camps of regenerative medicine, Sump quips that “They like to have me speak to the public because I’m the only one who doesn’t know enough to make it confusing.”
Born in Cleveland, Sump attended Ohio State University, earning a bachelor’s in zoology. She then went into regenerative medicine, taking her graduate degree at Case Western University.
Sump began helping commercializing DNA purification kits for the small Cleveland biotech firm Amrosco. She joined the Cleveland Clinic in 2002.
“This is not a 10-years-down-the-road issue; bioregeneration is very much a today issue,” says Sump. “The challenges we face now are less fine tuning theory than bringing regeneration into common, commercial practice.”
Of course, the red flag thrown up by the very term “cell regeneration” is the use of embryonic stem cells. Sump dismisses this instantly by assuring the opposition that embryonic stem cells are not used in the Cleveland Center to grow new tissue. Rather, the technology demands adult stem cells be implanted in the inflicted area to begin the bioregenerative process of healing.
Regeneration’s next step. Ask any country doctor and he will assure you that it is not he, but rather the body that performs the healing. Cells repair themselves quite naturally on their own, if given the proper environment. Traditional medicine works to provide that environment. Bioregeneration not only works to enhance the environment, but often to supply fresh, uninjured cells into it.
In some cases, biomaterials medicine operates by introducing devices, such as stents, which become part of the body to take over an unusual function, required by an usual situation — for example, a basket to catch clots and stop them from flowing brainward.
In other cases cells themselves are inserted to morph and multiply into the diseased or traumatized cell area. Getting the right cell for the job is only a third of the process. The cells must also be surrounded with a bioactive factory — proteins that tell the new cells what to do.
Thirdly, the new cells require a scaffold. Naturally, cell membranes exude a carbohydrate goo that aids in this connection and replication. “It looks like a little bottle brush around the cell and helps give the newly introduced cells a place to rest and join the existing ones,” Sump explains. “Hyaluronan is one such natural substance we are currently synthesizing.” When all three factors are in place, the regenerative healing can begin.
Money. “Shifting the treatment of a trauma or disease from a laboratory setting into a production setting requires lots of money,” says Sump. The first laboratory step is the theory that a given cell might positively affect such-and-such a disease. This leads to researching technology. Sump points out that somewhere along this second step, the question of relevance gets defined and redefined.
The success of this stage scarcely puts an end to the creativity. It merely leads onto the equally challenging developmental stage of what to put in the clinician’s hands to make it a workable, practiced healing tool. “When you have that, you have a potential product,” says Sump. “And that is where you really feel the sense of contribution coming in. Not only are you bringing about the humanitarian goal of improving individuals’ health, and the art of healthcare overall; you are making real products, adding jobs, and creating new opportunities.”
Hurdling the barriers. As idealistic as this all sounds, the course from the test tube to the hospital or drug store shelf seldom runs smoothly. The first and far greatest barrier to this translation process is money.
Venturists and banks tend to shy away from startup R & D companies because of the enormous amounts of equipment and highly-paid man hours required before there is even hope of product development. Even if the company is already vibrant and successful, the time from launching a biodevice or therapy is typically three to eight years. This frequently means tens of millions of dollars in investments before the initial returns.
The medical regulatory process is infamously slow in the best of cases. Years of animal and then human testing requiring mounds of documented data, stacked literally as high as a man, takes seemingly forever to generate, and even longer to get reviewed. But in the field of biomaterials, the bar has been raised even higher.
The final hurdle to biomaterial’s commercialization is stated in Sump’s own presentation: “If you build it, they may not come.” Companies must be convinced that the steep and costly learning curves for their clinicians will have a payoff. Clinicians themselves must see the benefits not only in understanding the mechanics, but in the mechanism itself.