The Rutgers-Cleveland Clinic Consortium has clinical trials of therapies for some of the most difficult challenges military medicine faces in the care of severely injured warriors.
Scar Remediation Clinical Trial (currently enrolling)
Significant damage and deformity can be caused by scars over large areas of the body. Such extensive scars usually result from burns. RCCC is exploring a new, minimally invasive surgical procedure involving the transfer of excess fat from the patient in order to remediate (or reduce) scarring. This fat transfer procedure has been performed on thousands of patients receiving ‘cosmetic’ surgery. However, these outpatient procedures were never given a serious scientific review. This clinical trial led by Adam Katz, MD, of the University of Florida, will scientifically test the potential and limitations of fat tissue transfer to speed healing and re-shape existing scars. Patient enrollment is open at the University of Virginia and pending at the USA Institute of Surgical Research and the University of Florida.
Face Transplant Clinical Trial for Extensive and Deep Injuries to the Face (currently enrolling)
In 2008, Dr. Maria Siemionow and her team at the Cleveland Clinic performed the first successful face transplant in the United States. This operation restored function to a civilian woman who lost her nose, entire upper jaw and mid face in a shotgun injury. The entire mid face from a donor who had died was transplanted. Dr. Siemionow and her team are continuing to develop this therapy that could benefit a large number of warriors who have suffered major trauma to the face, have had upper limb amputations, or combination injuries to face and limb. The loss of the face is a horrible injury, making the injured warrior feel especially bad about himself or herself and creating huge obstacles to returning to civilian life.
Kidney Transplant Clinical Trial (currently enrolling)
The Siemionow group is using a therapeutic antibody, TOL-101, as a conditioning agent prior to transplantation to enhance allograft tolerance. The researchers are testing the safety and tolerability of TOL-101 in patients who are undergoing their first kidney transplantations. The hypothesis of this clinical trial is that by using a selectively blocking T-Cell Receptor (TCR) antibody, TOL-101 will result in a lower incidence of opportunistic infections; faster recovery of the immune system in kidney allograft recipients; and better functional outcomes, as confirmed by kidney function assays and kidney biopsies. A total of 28 subjects have been enrolled in the Phase 1/2 clinical trial to date. The planned regulatory pathway for TOL-101 includes the design of a Phase 3 trial at the conclusion of the current study. If this trial is successful, we plan to use this drug as anti-rejection therapy for face tranplant patients.
Nerve Biopsy Clinical Trial (pending)
At the Mayo Clinic, 200-250 sural nerve biopsies are performed year year. Whole sural nerve biopsy results in predictable loss of function in the sural distribution of the foot. Reconstruction of the sural nerve in these patients can potentially restore sensation and prevent complications associated with the biopsy. The Windebank/Yaszemski group at the Mayo Clinic is aiming to repair post-biopsy sural nerve defects with a synthetic nerve conduit constructed from poly(caprolactone fumarate) (PCLF). Since the nerve is just below the skin, potential morbidity from the conduit will be readily identifiable and the device can be removed and analyzed. This will provide a platform for determining safety and an indication of efficacy of scaffolds to support nerve regeneration across larger gaps. This clinical trial is expected to begin enrolling patients in 2012.
Engineered Skin Substitute Clinical Trial to Treat Life-threatening, Extensive, 3rd Degree Burns to More Than 50% of the Total Body Surface Area (pending)
Because acute and long-term clinical management of severely burned warriors is among the most difficult and most expensive challenges of the military health care system, RCCC made the development of an engineered skin substitute as one of its high-priority goals. This substitute is ‘autologous’, meaning it uses the warrior’s own skin. Based on the work of Dr. Steven Boyce at the University of Cincinnati, a small section of healthy skin can be expanded significantly in a tissue culture laboratory. At the end of three weeks, there will be enough skin to cover large body surface burns. Unlike skin grafts from donors, RCCC's skin substitute consists of the patient's own cells, does not cause an immune reaction, and is fully reintegrated into the patient's body. This eliminates the need for extensive and repeated skin grafting. The autologous skin device will become available to treat patients with full-thickness burns of greater than 50% of the total body surface area. This technology will save the lives of the most severely burned warriors, and it can improve their overall appearance, while shortening their stay in an intensive care unit. One of AFIRM's industrial partners, Lonza Walkersville, Inc., and surgeons at the US Army Institute of Surgical Research and the Brooke Army Medical Center in San Antonio are currently working together to potentially begin enrollment in late 2012.
Ex Vivo Produced Oral Mucosa Equivalent (EVPOME) to Treat Large Intra-oral Defects (pending)
One of the greatest challenges of facial injury repair is the limited supply of oral tissue or mucosa needed to
rebuild a large mouth wound. One option is to use a skin patch to cover the wound. However, skin tissue
neither looks and acts like real oral tissue, nor does it have comparable functional properties. In order to
address these challenges, Dr. Stephen Feinberg, DDS, at the University of Michigan has proposed use of
an Ex Vivo Produced Oral Mucosa Equivalent (EVPOME) to act as a replacement for skin grafts. In this
Phase I/II clinical trial, EVPOME will be compared to AlloDerm®, the current standard for intraoral
reconstructive procedures. Ten subjects will be enrolled for each treatment group. This study, to be
conducted at the University of Michigan, will assess safety as determined by graft success/failure or
absence/presence of adverse events. A proof-of-concept study using this material has already shown
technical feasibility with no adverse events. FDA and IRB approvals of this proposal are expected in late
For more information on clinical trials, contact us here.