Regenerative medicine accelerated from the bench into the practice in new ways in 2019, ushering in an era of care focused on the body’s amazing ability to heal itself. Bolstered by robust research, Mayo Clinic is at the forefront of delivering new therapies that restore form and function to diseased cells, tissues, or organs — and ultimately to the individual as a whole. 

“The regenerative toolkit keeps on expanding concomitantly, and applications of regenerative medicine into practice is increasingly broadening to more conditions that benefit more patients. Across Mayo Clinic sites and specialties, from neurosurgery, neurology, otorhinolaryngology, pulmonary medicine, cardiology and cardiac surgery to cancer and musculoskeletal care, women’s health and plastic surgery, medicine, laboratory medicine and radiology, this year has seen remarkable achievements,” says Andre Terzic, M.D., Ph.D., director of Mayo Clinic Center for Regenerative Medicine. 

Redefining health care

Regenerative medicine is redefining clinical care, going beyond mitigating disease symptoms to addressing the underlying cause. Mayo Clinic aspires to cure, connect and transform through new regenerative therapies grounded in rigorous science and in line with regulatory standards for quality and compliance.

Within the next decade, regenerative medicine is predicted to account for 10% of all clinical care. As a prelude to the years to come, Dr. Terzic points to inspiring examples that have highlighted regenerative care in 2019 at Mayo Clinic:

Regenerative immunotherapies are transforming cancer care

Mayo Clinic is one of a few select medical centers in the United States to provide chimeric antigen receptor (CAR) T-cell therapy  in a clinical setting.  CAR T-cell therapy unleashes the body’s immune system to go on search and destroy missions, targeting blood cancers, particularly B-cell leukemias and lymphomas.  In the past year, the number of clinical trials involving CAR T-cell therapy has doubled; there are two newly approved drug options offered for leukemia and lymphoma; and additional new therapies are expected to clear U.S. Food and Drug Administration approval in early 2020.

Neurosurgery is offering new hope for spinal cord injury

Early research at Mayo Clinic shows that stem cell intervention in the lumbar, or lower back, offers hope for people paralyzed from spinal cord injury. A Mayo Clinic case study found mesenchymal stem cells derived from a patient’s own fat injected after standard surgery and physical and occupational therapy restored bodily function in the first person tested. The patient, a 53-year-old man paralyzed in a surfing accident, has shown significant gains in standing, walking and gripping strength.

A second surgical procedure is referred to as spinal cord bypass.  An implanted stimulator bypasses the area of spinal injury, restoring the body’s ability to send messages to and from the brain.  Mayo Clinic research has shown this type of spinal cord stimulation helped a man paralyzed since 2013 regain ability to stand and walk with assistance, regenerating information flow around the severed lesion.

Larynx and lymph node transplant: breakthroughs in regenerative surgery

Mayo Clinic launched a first of its kind transplant program in its Arizona Otorhinolaryngology practice to restore function for people that have had their larynx, or voice box, removed.  The United Network for Organ Sharing (UNOS) has given its first approval for this procedure to Mayo Clinic. A successful larynx transplant allows a patient to breathe through the mouth, swallow normally and produce a human-sounding voice instead of breathing through an opening in the neck and communicating by machine or special prosthesis.

“This formidable achievement underscores the collective ability of Mayo Clinic to not only advance innovation but to do it in a way that is systematic and meets the highest stringency for bringing a concept into the practice,” says Dr. Terzic.

Concomitantly, in Plastic Surgery, lymph node transplants are showing promise as a therapy for lymphedema — a painful blockage of the lymph system that causes fluid buildup commonly seen in patients treated for breast cancer. Healthy lymph nodes are transplanted to replace the diseased counterparts, promoting regrowth of the lymph system.  

New procedures in maternal fetal medicine enable correction before birth

Initially it was thought that regenerative medicine would mainly address issues related to diseases of aging. However, research at Mayo Clinic increasingly shows that regenerative medicine interventions can tap the strong healing abilities of a young child or even be beneficial prior to birth.

Two recent examples of fetal surgeries led by a Gynecology and Obstetrics specialist and performed at Mayo Clinic through U.S. Food & Drug Administration-approved clinical trials include:

Fetal endoscopic trachea occlusion surgery  which seeks to correct underdeveloped lungs caused by severe congenital diaphragmatic hernia (CDH) — a condition in which internal organs push up against developing lungs, stunting growth. Without this surgery, 70% of infants born with severe CDH die. The surgeon places a balloon in the fetus’s trachea, causing the lungs to regrow and expand enough for the baby, at birth, to eventually breathe without assistance.

Minimally invasive fetoscopic repair of spina bifida  is another procedure under clinical assessment done in the second trimester of pregnancy to repair a birth defect that occurs when the spine and spinal cord don’t form properly.

Areas of advancements to watch in 2020

• Regenerating organs for transplantation — Research at Mayo Clinic’s Florida campus will seek to address the shortage of donor organs by regenerating or rebuilding the health of organs previously considered not viable for transplantation.  
  
  
• Biomanufacturing new products that promote healing — Mayo Clinic has a targeted investment in biomanufacturing of new cellular, acellular and tissue products that offer patients new options for healing. Opportunities to scale production for increased accessibility, affordability and cure rates are prioritized.
  
  
• Educating the workforce of the future —Mayo Clinic is training the next generation of physician-scientists through regenerative medicine curricula that transcends the educational shield. Efforts are underway to develop a dedicated regenerative science track at the graduate school level and to train all medical students to become proficient in regenerative medicine.
  
  
• Developing industry collaborations to speed new therapies to market —  Mayo Clinic is forging new industry collaborations to bring to market new regenerative therapies for the benefit of patients around the world.
  

“It is an exciting time as regenerative medicine applications continuously expand across disease conditions,” says Dr. Terzic.  “Regenerative medicine is driven by patients seeking regenerative solutions. Therefore, we have a moral and societal mandate to ensure the validity and ultimately the utility of these newest therapies.”

Mayo Clinic will continue to advance its regenerative care  toolkit to address unmet needs of the patient  and to advance Mayo Clinic’s vision  to “cure, connect, and transform” health care in 2020 and beyond.

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Dr. Terzic is the Michael S. and Mary Sue Shannon Director, Mayo Clinic Center for Regenerative Medicine, and Marriott Family Professor in Cardiovascular Diseases Research.

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