FRIDAY, MARCH 27 -- What happens to clinical trials when an unprecedented global outbreak shuts down life as we've known it? The answer, as with most things right now, is -- It depends.
The Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome (HLHS) currently has a Phase IIb clinical trial open at seven hospitals in the US through the HLHS Consortium. Stem cells taken from a baby’s umbilical cord blood (UCB) are injected into the babies’ own heart during a surgery to repair the congenital heart defect with the hope of strengthening the heart. Our team has been performing cell deliveries since 2013, and typically brings the frozen cells from our lab in Rochester, Minnesota directly to the hospital where the surgery is being performed.
Hospitals are currently reviewing which studies offer a potential benefit to patients and which should be modified or put on hold to avoid exposing patients to unnecessary risk. As of today, all hospitals in the HLHS Consortium have determined that our UCB Collection Study and Phase IIb Cell Delivery Study both offer a significant potential benefit that outweighs the risks, and will continue to enroll and treat patients on our trials.
We are also doing our part to further minimize possible risks during this time. For example, all non-laboratory staff began working from home in mid-March. (We have so many people on video calls, we hum 'The Brady Bunch' theme song at the start of each meeting.)
Essential lab staff are taking steps to ensure that our ongoing cord blood collection and processing is done safely. In addition to our normal sterile field clean room processes, staff are working alternating shifts, regularly disinfecting surfaces, and conducting verifications virtually to reduce the number of staff on-site. Additionally, while our cell delivery team (pictured above) usually flies to sites on commercial airlines, our program is currently chartering the Mayo Clinic Air Ambulance airplane to reduce exposure and keep our staff and patients as safe as possible.
We remain committed to conducting the vital work of bringing hope to CHD families through the development of regenerative medicine products. However, we respect that the situation is rapidly changing, and will only continue our work when and where it is safe to do so. We will continue to evaluate each cell delivery treatment on a case-by-case, site-by-site, and day-by-day basis.
We appreciate your understanding and support. Please feel free to contact us at HLHS@mayo.edu if you have any questions or concerns. Thank you for your efforts to keep our communities safe during the COVID-19 pandemic.