Resident completes pre-clinical trial, FDA approval needed before next phase can begin
Date: 2/14/2014
By Carley Dangona
carley@thereminder.comSOUTHWICK – Resident Marita Niquette awaits approval from the U.S. Food and Drug Administration (FDA) to see if she will be a candidate for a groundbreaking injection to restore the use of her legs.
Niquette completed a boot camp conducted by the Miami Project to Cure Paralysis this January, where participants with chronic spinal chord injury (SCI) took part in a rigorous physical therapy program to increase the functionality of atrophied muscles.
The clinical took place from Aug. 26 to Dec. 13, 2013 with another week of treatment in January 2014. Niquette has been in a wheelchair since 1985 after suffering a SCI during an automobile crash.
The results of the study will be submitted to the FDA in March. If approved, the candidates would be eligible for Schwann cell transplantation. According to the Miami Project (www.themiamiproject.org) website, the cells are implanted into a patient’s cord and build a bridge to the existing tissue, resulting in improved movement. Upon approval, the next phase of the study would begin later this year.
“I have no regrets for taking part in the study,” Niquette said. “I gained increased muscle tone, energy, physical fitness and overall better shape then when I first started the boot camp study.”
She continued, “The most difficult part of the experience was having to also work full-time (40 plus hours a week) for my job and go to the hospital Monday through Friday for three plus hours a day to do participate in the study.”
Niquette lived in Miami, Fla., during the study and telecommuted to work at MassMutual where she works in the Benefits Account Consulting department. She said that without the option to work remotely, she would not have been able to take part in the study.
According to Niquette, therapy session included the trial sessions consisted of circuit training, the locomotor, which is a device that places wheelchair-bound people upright and enables them to walk with mechanical aid, and the Functional Electrical Stimulation (FES) bike, a device that uses electrical currents to stimulate nerve cells.
“I liked everything equally because they all made me feel better and helped me get in better shape,” she stated.
When asked what is next, Niquette responded, “Next in my life is to continue to stay in shape and continue working full time and enjoying every day to the fullest.” She added that she will continue a workout routine of her own design.
“I feel very blessed to have been selected to be part of the study and hope that the FDA will approve the Schwann cell transplantation for chronic injured spinal cord injuries,” Niquette commented.
