Northwestern University Stem Cell Therapy Clinic Closes Abruptly

A Chicago-based center that has long operated a clinical trial program for stem cell therapies, has stopped recruiting further patients as its chief, Richard Burt, leaves for a research sabbatical.

Sep 6, 2019

KATARINA ZIMMER

(https://www.the-scientist.com/news-opinion/northwestern-university-stem-cell-therapy-clinic-closes-abruptly--66401)

A pioneering stem cell clinical trial program in the US is closing up shop, a surprise move for what had appeared to be a successful endeavor at testing hematopoietic stem cell transplantations (HSCT) for autoimmune and other diseases. Northwestern Medicine’s immunotherapy and autoimmune diseases program, based at Northwestern Memorial Hospital in downtown Chicago, will no longer accept new patients for clinical trials, a spokesperson for Northwestern Memorial HealthCare confirmed this week (September 5).

The center specializes in conducting hematopoietic stem cell transplantations (HSCT), whereby stem cells are intravenously infused into a patient whose bone marrow or immune system is defective due to disease. The stem cells are obtained from a patient’s own bone marrow or peripheral blood, or that of another person. Patients are typically treated there as part of clinical studies testing the use of HSCT for autoimmune diseases, such as multiple sclerosis (MS), and systemic lupus erythematosus, but sometimes also outside of trials as part of an FDA-sanctioned program known as “expanded access,” according to Science.

The reason for the center’s closure is that its chief, Richard Burt, will be taking a research sabbatical to teach the HSCT protocol he’s developed to other clinics across the US and writing a book requested by a textbook publishing company, he tells The Scientist.

Some in the field question why the program can’t continue without him. “If his program is so successful, [why] it should suddenly stop if he’s not there is a little bizarre,” remarks Mark Freedman, a neurologist who directs a research division focused on multiple sclerosis at Ottawa Hospital. Burt and Northwestern did not say why the program could not continue without him.

The news of the closure, which first surfaced on a Facebook group for patients with autoimmune diseases being treated with HSCT, follows promising results from a multiple sclerosis trial reported by Burt and his colleagues in January. The study—one of a handful worldwide that have investigated HSCT for multiple sclerosis—suggested that HSCT proved a more effective treatment than conventional drugs in a majority of patients who had suffered relapses of the disease after a first line of standard treatment.

Earlier this month, actress Selma Blair reported on Instagram that she can “walk much better” after having undergone the HSCT treatment for multiple sclerosis at the clinic, but is still recovering from the chemotherapy, which is used to deplete the body’s immune system before receiving the stem cells.

Burt’s work has attracted some concern in the past due to a letter he received in November 2016 from the US Food and Drug Administration (FDA), containing a list of violations in the conduct of clinical studies at Northwestern, including the failure to report patient deaths and adverse events experienced by patients to the FDA in a timely manner.

Burt stresses that the closure of his clinic is not linked to issues cited in the FDA letter. “In December 2016, the FDA sent a follow up letter saying our response was satisfactory and that there were no further actions or questions. The FDA found no treatment-related deaths in any of the studies,” he writes to The Scientist in an email.

During his upcoming research sabbatical, he plans on working with universities and clinics across the country to make the HSCT protocol he’s developed more widely available. “This is in my assessment . . . the best way to help the world, and humanity, and help patients to move this forward, to get the treatment more widely around the world,” he says.