Next-level Dose Given in Trial of Stem Cell Therapy for Bradykinesia

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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IMAC Holdings has completed dosing the second group of patients in its Phase 1 clinical trial testing umbilical cord-derived mesenchymal stem cell therapy for the treatment of bradykinesia due to Parkinson’s disease.

About a year ago, a first group of five patients received a low dose of the therapy and this month, a second group of another five patients received a medium dose of the therapy, the company announced in a press release.

Now, the company will wait at least one month to check whether the medium dose is safe before starting to dose a third group of patients with a higher dose.

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Bradykinesia usually occurs early in the course of the disease and may manifest as slow and difficult movement. Movement may become smaller and more difficult to initiate. Over time, bradykinesia may lead to a flat facial expression, a shuffling walk, and a limited ability to perform daily activities.

Although the mechanisms leading to bradykinesia remain unclear, inflammation is thought to play a role.

Stem cells have the capacity to continuously divide and differentiate into various cell types. As such, they are seen as a potential treatment in regenerative medicine for neurological disorders such as Parkinson’s. Mesenchymal stem cells are adult stem cells present in many tissues, including the umbilical cord, bone marrow, and fat. Because of their anti-inflammatory properties, these cells may help to treat bradykinesia by modulating the immune system and easing inflammation.

The goal of this Phase 1 study (NCT04385056), currently underway in three locations across the U.S.,  is to evaluate the safety and tolerability of umbilical cord-derived mesenchymal stem cells to treat bradykinesia. Its primary goal is to assess the number of side effects occurring during the course of one year.

The therapy involves a procedure called an allogeneic stem cell transplant. During the procedure, a patient receives mesenchymal stem cells from a healthy donor to replace their own stem cells. This is done via a one-time intravenous (into-the-vein) infusion.

The clinical trial will include a total of 15 patients 55 or older who have had bradykinesia for at least three months prior to the start of the study. The patients are divided into three groups: low, medium, and high doses.

In charge of supervising the clinical trial is Ricardo Knight, MD, who directs the Mike Ditka IMAC Regeneration Center in Arlington Heights, Illinois.