Stem cells could be a ‘revolutionary treatment’ for dysphagia after cancer treatment



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Researchers at the University of California, Davis Health, have begun a clinical trial using stem cells to treat dysphagia associated with tongue damage caused by cancer treatment.

In the REVIVE trial, researchers will evaluate a new technology in which stem cells taken from a biopsy of a patient’s thigh muscle are injected into the patient’s tongue. Researchers hypothesize that stem cells may fuse with existing muscle fibers to strengthen tongue muscles and improve swallowing ability.



Quote from Dr. Jonathan David Anderson



The study builds on positive data obtained in Phase 1 trials of this approach, according to the company. JonasahDr. David Anderson, Assistant Professor at the University of California, Davis Institute for Regenerative Medicine.

“The Phase 1 data look very encouraging. If the trends in the data hold true for the Phase 2 and Phase 3 trials, we will be looking at a unique and innovative treatment for patients with dysphagia.” will be,” Anderson told Helio. “That’s the big hope and the promise of stem cell therapy.”

Anderson told Helio about the positive results of the Phase 1 trial, the current challenges to enrolling in Phase 2 trials, and the potential of this approach to alleviate this unpleasant side effect of cancer treatment.

Helio: What made you want to study this?

Anderson: Patients with dysphagia have a poor quality of life. The patients we treat have head and neck cancer and are at risk of death. Then you will have cancer treatments such as chemotherapy, radiation therapy, and surgery. Many patients survive and initially appear to be in good health. However, because radiation causes progressive collateral damage, problems can develop in the tissues surrounding the tumor slowly and gradually over time.

Perhaps unintuitive about this process is that cancer treatments generate successive waves of tissue damage and remodeling that occur over years, even decades. As a result of the toxicity of this cancer treatment, the muscles around the tongue and base of the throat begin to atrophy and eventually the amount of scar tissue begins to increase. Eventually, it can be very difficult for patients to swallow their own saliva, let alone food. They may have difficulty speaking and socializing, which can lead to depression. Additionally, some of these patients experience further sequelae such as aspiration pneumonia and may rely on feeding tubes to maintain adequate nutrition.

One of the current standard treatments for these patients is tongue training at home. Although effective, they cannot stop the progression of the disease. It just slows down your progress.

This new stem cell therapy approach began several years ago when it was adopted by the University of California, Davis. Dr. Jean A. Norta, To run a stem cell therapy program. Many researchers in regenerative medicine have high hopes that stem cell therapy will bring about a new paradigm shift in how patients are treated.

The people running our clinical trials Peter C. Belavski, MD, MPH, PhD, Considered one of the key innovative leaders in the field of dysphagia and dysphagia. Belavsky and Norta developed an interesting idea. What if a patient’s own stem cells could be used to help regenerate lost muscle tissue? The idea is that these muscle stem cells are injected and transplanted into the muscles at the base of the patient’s tongue. This adds size and contractile force to one of the key muscles involved in effective swallowing.

Another interesting aspect of this story is that some of Belavsky’s dysphagia patients provided the initial funding to start this project. None of this would have been possible with the generous support of these patients. We then worked with Cook MyoSite to bring this idea into the clinical trial process. Recently, we added another partner, the California Institute for Regenerative Medicine, and he was awarded an $11 million grant to test these muscle stem cell therapies in Phase 2 clinical trials. We were lucky to have great partners throughout this process.

Helio: How does this measure up in the human population?

Anderson: Once a patient is screened and found to be eligible to participate in a trial here at the University of California, Davis, a thigh biopsy is taken to obtain a small piece of muscle tissue. We send the biopsy to her MyoSite to isolate and expand the muscle stem cells from the muscle tissue. Hundreds of millions of muscle stem cells are eventually obtained, frozen and sent back to Belavski, who injects them into the patient’s tongue at several sites. Dr. Belavsky repeats the injection procedure again about 4 to 6 weeks after the first dose. Patients will then be followed for two years so that the safety and effectiveness of this treatment can be closely evaluated. We also have a partner facility at the University of California, San Francisco, headed by a leading dysphagia doctor. Clark Rosen, medical doctor.

Helio: Who is eligible to participate in the trial?

Anderson: Patients must be previously treated for oropharyngeal cancer and within 24 months of completion of treatment. Additionally, patients must have mild to moderate swallowing problems. So, for example, to be eligible for this study, a patient must be able to take more than 50% of her food orally rather than through a feeding tube.

Helio: how was this treatment pHase 1 trial?

Anderson: What we saw was quite amazing. The disorder is generally progressive, so patients experience a decline in swallowing function over time. A treatment that keeps patients stable without worsening over time would be a big win for them. Interestingly, a phase 1 study showed improvement in tongue strength in these patients one year after he received the treatment injection. This is an outstanding finding, and if it continues beyond this Phase 2 trial, it would be game-changing for these patients. That said, Phase 1 studies are generally small and primarily aimed at assessing the safety of such treatments. Only a Phase 3 trial will allow us to feel the true efficacy of this treatment with certainty.

Helio: Is there anything else you would like to mention?

Anderson: We are still looking for patients, so if you are interested, please contact us below. HS-ENTStemCell@ucdavis.edu. Although this is a placebo-controlled study, patients in the placebo group will receive free stem cell therapy at the end of their participation. In addition, we have a fund to offset a portion of the costs of out-of-area patients.

For more information:

JonasahDavid Anderson, PhD, The contact is UC Davis Institute for Regenerative Cures, 2921 Stockton Blvd., Sacramento, CA 95817. Email: HS-ENTStemCell@ucdavis.edu.



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