UC Davis Well being researchers have begun a brand new scientific trial that makes use of stem cells to deal with sufferers with swallowing issues associated to tongue damage from most cancers therapy.
The trial known as REVIVE. It includes a novel approach the place researchers take stem cells from a biopsy of a affected person’s thigh muscle and inject these stem cells into the affected person’s tongue. Researchers consider the stem cells will fuse with current muscle fibers to extend tongue energy and sufferers’ means to swallow.
“For this research, we’re growing a therapeutic strategy utilizing autologous muscle-derived cells [AMDCs] to see if there are any advantages to swallowing perform for sufferers with dysphagia,” defined Peter Belafsky, director of the UC Davis Well being Middle for Voice and Swallowing and the principal investigator of the research. “The preliminary outcomes of our Part I trial indicated that AMDCs injected into the tongue of our sufferers with dysphagia had been protected and considerably elevated tongue energy.”
Annually, about one in 25 adults will expertise a swallowing downside in the USA. Many of those folks have acquired therapy for head and neck most cancers, which may harm the muscle mass chargeable for a protected and efficient swallow. At present, there aren’t any efficient remedies to enhance swallowing.
“This remedy may very well be a game-changer for our sufferers that suffer from problem swallowing, a lot of whom are most cancers survivors dwelling with the results of radiation toxicity,” Belafsky stated.
This remedy may very well be a game-changer for our sufferers that suffer from problem swallowing, a lot of whom are most cancers survivors dwelling with the results of radiation toxicity.”
Medical trial design
The research is a double blind, placebo-controlled scientific trial – that means neither the individuals nor the researchers know who’s receiving the stem cell therapy or placebo. Nevertheless, the placebo sufferers will likely be provided the stem cell remedy as soon as they’ve reached the purpose within the research the place they’ll be unblinded.
For the research, researchers take a biopsy of a affected person’s thigh muscle and ship it to Prepare dinner Myosite Inc., who developed the cell remedy that isolates the muscle stem cells. This course of permits them to extract the AMDCs from the affected person’s muscle tissue and develop the cell inhabitants to over 300 million cells per affected person.
Sufferers receiving the therapy may have two pictures of 150 million AMDCs injected into their tongue, spaced 4-6 weeks aside. When injected, AMDCs can fuse into the muscle fibers of the tongue. It’s anticipated that AMDCs will improve tongue energy and enhance sufferers’ means to swallow.
Sufferers given the placebo will likely be provided the chance to obtain the stem cell therapy after they’re unblinded, two years after the preliminary therapy.
Seek for a therapy
For the research, researchers are working to determine and recruit 62 sufferers at two scientific websites: UC Davis Well being and the College of California, San Francisco.
Members ought to:
- Be 18 years of age or older
- Have delicate to reasonable swallowing problem following head and neck most cancers therapy
- Be no less than 24 months previous their final most cancers therapy
Journey funds can be found for sufferers who want to take part at both of the 2 trial websites, UC Davis Well being or UC San Francisco.
Members additionally have to be dedicated to finishing the research. It includes eight in-office visits and 7 digital visits over the course of 26 months, at both UC Davis Well being or UC San Francisco.
The research is funded by a grant from the California Institute for Regenerative Drugs. Further investigators on the research embody Clark Rosen, director of the UC San Francisco Voice and Swallowing Middle and chief of the laryngology division.
For extra data, contact the research staff at HS-ENTStemCell@ucdavis.edu or go to the trial’s web site.