Fiocruz Bahia to carry out clinical trial with stem cells to treat paraplegia

Fiocruz Bahia will carry out the first Fiocruz clinical trial of advanced therapies (with the individual's own stem cells) approved by the National Health Regulatory Agency (Anvisa), with the aim of testing a treatment for paraplegic patients who have suffered spinal cord trauma.

Advanced therapies are cell, gene and tissue bioengineering therapies, and are considered a new category of drugs by Anvisa. The trial, coordinated by Fiocruz Bahia researcher Milena Soares, was approved in November, after analysis of the dossiers submitted.

"To carry out any clinical trial involving advanced therapies, Anvisa's approval is first required, and this is important news at a time when Fiocruz is expanding its advanced therapy development program. Brazil is a highly regulated country when it comes to cell therapies, which is essential for the protection and care of the Brazilian population," says Milena.

The approval of the trial is the result of Fiocruz's partnership with Senai Cimatec, the institution where the patients' stem cells will be produced in a certified laboratory. With the participation of 40 patients and an expected length of three years, the trial will assess treatment with stem cells from the patient's own bone marrow.

"It is a line of research that we've been developing for more than 15 years and we intend to validate it by assessing the efficacy and safety of the treatment. If the therapy is shown to be effective and safe, we hope that in the future it can be offered in the Unified Health System (SUS) to help improve the quality of life of these people," explains the coordinator.