Why Choose Us
Comprehensive program: Cleveland Clinic’s Center for Regenerative Medicine and Surgery offers novel clinical trials while maintaining excellence in standard of care. This allows our patients to establish a multidisciplinary care team during their time at Cleveland Clinic.
Team based approach: Our experts continually seek to improve care of patients with a multidisciplinary team based approach, including the latest research and technology.
Leader in human clinical trials: Our Center has six active studies which are on track to enroll over 100 patients that treat disease indications such as perianal fistulas, ileal pouch fistulas, rectovaginal fistulas, Crohn’s colitis and ulcerative colitis. The program has also treated emergency cases in patients with intestinal bowel transplant rejection, liver transplant rejection, face transplant rejection and primary sclerosing cholangitis.
Superior outcomes: We are focused on delivering the highest level of care for our patients. We track our outcomes measures to hold our team accountable for delivering the highest level of care.
What We Treat
Treatments and Procedures
Cell therapy, derived from healthy donors in an ex vivo fashion, is given via local injection to an area of disease or inflammation or given systemically depending on the protocol. In the majority of our current trials, the cells are delivered locally directly to the area of inflammation.
Please browse our clinical trial treatment overview videos.
Note: please add the below videos into players that can be viewed on this page
Meet Our Team
- Amy Arsuaga, RN, Care Coordinator
- Ciera Wells, Administrative Assistant
- Taylor Boice, APRN/PA
- Kavita Elliot, Project Manager
- Mark Wentworth, Regulatory Manager
- Caroline Matyas, Study Coordinator
Surgery and Transportation
- Douglas Nachand, MD
- To make an appointment with the Center for Regenerative Medicine and Surgery, please email [email protected] or call 216.445.9715.
- For 24/7 scheduling, please call 216.444.7000 and ask to be scheduled with Dr. Lightner in Colorectal Surgery.
Patient Information Binders:
- Mesenchymal Stem Cells for the Treatment of Crohn’s Colitis
- Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis
- Mesenchymal Stem Cells for the Treatment of Pediatric Perianal Fistulizing Crohn’s Disease
- Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn’s Disease
- Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn’s Disease
- Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Crohn’s Disease
Clinicaltrials.gov - a database of privately and publicly funded clinical studies conducted around the world.
For Medical Professionals
To refer a patient to the Center for Regenerative Medicine and Surgery, please email [email protected].
Read our latest posts on Consult QD, Cleveland Clinic's blog for physicians and healthcare professionals.
What is a mesenchymal stem cell?
Mesenchymal stem cells are adult stem cells that can be harvested from bone marrow or fat tissue. They are adult cells that your body uses to repair tissue that is injured. We are able to isolate these cells and deliver them in large numbers right to where the tissue is inflamed or injured to promote healing.
Where do the mesenchymal stem cells come from?
Mesenchymal stem cells for our clinical trials are retrieved from the bone marrow of healthy donors. The donors are screened for several items just as blood donors are screened.
How do mesenchymal stem cells work?
Mesenchymal stem cells act as a potent anti-inflammatory by secreting factors called cytokines into the tissue. These cytokines have anti-inflammatory properties. They also recruit immune cells that are normally in low levels that are needed to heal these areas of injury. In late phases, they help regenerate, or repair, tissue to return it to a healthy state.
Do mesenchymal stem cells stay in my body after injection?
Mesenchymal stem cells are likely in the body only 3-7 days, although we are unable to know for sure, since we can’t label these cells and see them. We have learned this information from animal studies that have been done. They are in the local area and secrete their cytokines, or signals, which change the local environment in the tissue and then lead to their anti-inflammatory and repair properties.
Do mesenchymal stem cells turn into something else after injection?
Because mesenchymal stem cells are adult stem cells they don’t turn into other cell types or tissues like ‘embryonic stem cells’. These mesenchymal stem cells really serve as anti-inflammatory and repair cells.
Will my body react against the cells or be ‘rejected’?
Mesenchymal stem cells don’t have markers on their surface that would make your body recognize them as foreign. Therefore, your body won’t react against them or reject them.
Are there any risks of these mesenchymal stem cells?
There do not appear to be any significant risks of mesenchymal stem cells. These cells have been used in inflammatory bowel disease since 2003. There have now been hundreds of patients treated without any reactions or infections or complications related to the cells. Thus, we now have several years of safety data using these cells for inflammatory bowel disease and have strong evidence there are no clinical concerns.
How can I learn more about a clinical trial?
You or your doctor can reach out to us for more information. Our team can be reached via email at [email protected]. We will contact you and register you as a patient if you would like. Then we can set up an in-person visit with Dr. Lightner or a virtual visit. Before the visit, the doctor’s nurse will reach out to ask you a few questions so that we can understand your IBD history and which records we need to obtain before your appointment. We may need to obtain lab work, colonoscopy reports, CT and MRI imaging as well as any prior operative reports from previous surgeries.
What can I expect when I meet with Dr. Lightner?
Dr. Lightner will review the notes taken by her nurse of your outside records. She will then meet with you to discuss your IBD history and current symptoms to understand your IBD story. Then she will talk about treatment options which may or may not include participation in a stem cell trial. Sometimes, there are options that may help you before proceeding with a stem cell trial. Other times, it may be best to proceed right to a stem cell trial.
What might be some tests I need before enrolling into a clinical trial?
Depending on which clinical trial, and when you last had these tests, you may need to get imaging of your intestine (MR enterography or CT enterography), a surveillance colonoscopy, pelvic MRI to look at fistula tracts, and blood tests done.
Do I need to stop my IBD medications before a clinical trial?
This depends on which clinical trial you are participating in. If you are participating in a fistula study, you will remain on any IBD medications you are currently taking. If you are participating in a trial for intestinal disease, then likely you will be discontinuing current medications for your inflammatory bowel disease prior to receiving any stem cell treatment. However, this will be discussed with Dr. Lightner and the doctor prescribing your medication for inflammatory bowel disease.
How often will I have to come to Cleveland if I enroll into a clinical trial?
The clinical trials require being seen in person multiple times over the course of the year as these are trial monitored by our institution and by the Food and Drug Administration (FDA) for both safety and how well cell therapy works. Thus, we are responsible for your safety and clinical care. That is why we have to see you in person here in Cleveland. We understand this may be difficult if you are coming from out of town, but we can try to work with your schedule the best we can and schedule visits far in advance.
What can I expect on the day of procedure when I receive mesenchymal stem cells?
All stem cell deliveries are done in the operating room while you are asleep. You will report to the preoperative area and then when we are ready for your case to start you will be brought to the operating room. Dr. Lightner will see you outside the operating room to answer any questions and perform a team huddle with you, the anesthesiologist, the OR nurse and Dr. Lightner. Then you will go to sleep and the procedure will take about 30 minutes. After the procedure you will go to the recovery area where you will be monitored for a total of four hours. The four hours are required because you are receiving an investigational product and we have to make sure you don’t have any reaction to the product before leaving the hospital. Dr. Lightner will see you and talk to the family member/friend of your choice if you want following the procedure.