New studies in genomics show promising future for regenerative medicine
MIAMI BEACH, Fla. — During a presentation on genomics in regenerative medicine at South Beach Symposium, a speaker highlighted the impending release of clinical trial data as well as the start of a second trial that may advance the field.
“The possibilities of regeneration and reversing senescence may contain the most powerful healing tools that could be used in medicine to heal the human body,” Jill S. Waibel, MD, medical director at Miami Dermatology and Laser Institute, subsection chief of dermatology at Baptist Hospital and medical director of Miami Cancer Institute’s Multidisciplinary Skin Cancer Clinic, said during her presentation. “We are on the cusp of revolutionizing health care by establishing regenerative medicine.”
Although many regenerative therapies, particularly those including exosomes and stem cells, are revolutionary for patients, the malpractice that has come out of unapproved treatments has led the FDA to be “on the offensive,” Waibel said, adding that doctors need to be moving forward appropriately and not bypassing regulatory pathways.
To that end, Waibel highlighted two clinical trials focusing on genes and how they can identify mechanisms of action that are currently underway.
The first trial analyzed the treatment of nasolabial folds (NLF) using poly-L-lactic acid (PLLA) vs. calcium hydroxyapatite. Neither of these treatments are fillers; instead, they are both bio stimulators of the immune system.
This clinical trial included 30 patients who received two sessions of PLLA to NLF or calcium hydroxyapatite to NLF. After performing a baseline biopsy and 30-day biopsy, researchers detected 200 different gene markers. Waibel said that this is the first set of data that she received this week, which may lead to a better understanding of what genes were affected and the mechanisms of action. The full results should be ready in the next 2 to 3 months, according to Waibel.
The second trial, which was scheduled to begin this week, is evaluating the efficacy of micro-coring, which was hailed by R. Rox Anderson, MD, professor of dermatology at Massachusetts General Hospital and Harvard Medical School, as the “most exciting innovation in aesthetics,” according to Waibel.
This minimally-invasive, first-in-class device safely and effectively removes micro-sized portions of excess skin without surgery, thermal energy or evidence of scarring. This genomics study will be looking at panels of genes to help determine mechanisms of action and will utilize 3D photography to identify vector directional changes.
“It’s a regenerative medicine world out there,” Waibel said, “and it is here to stay.”