A company in Louisville is researching if cells taken from patients' fat could lessen knee pain and enhance movement in people with arthritis.
GID BIO is conducting a phase 3 trial of a process that extracts fat from the patient, uses a chemical reaction to isolate cells believed to have regenerative properties and injects them into the patient’s knee.
Phase 3 trials usually involve observing hundreds or thousands of volunteers for at least a year to determine if a treatment is effective and to clarify its potential side effects, as stated by the U.S. Food and Drug Administration.
The trial is not recruiting patients in Colorado, but if the therapy gets FDA approval, doctors' offices could easily adopt it here and across the country, said William Cimino, CEO of GID BIO.
Although fat tissue may not seem interesting at first glance, it contains various types of cells, including those that aid in rebuilding connective tissue and blood vessels, Cimino noted. These same cell types are available elsewhere in the body, but they are highly concentrated in fat, and most people don't mind giving up a bit of that particular tissue, he mentioned.
Researching cell-based therapies for arthritis is challenging because individuals often report significant relief from placebos, making it difficult to determine whether the relief they experienced was due to the treatment or simply because they believed it would work, said Dr. Cato Laurencin, CEO of the Cato T. Laurencin Institute at the University of Connecticut, who studies fat-derived therapies but is not affiliated with the GID BIO trial.
However, studies using different approaches have shown signs that some of the chemicals produced in fat can assist in tissue regeneration, he stated.
“The potential is absolutely tremendous,” he said.
Many people believe that the breakdown of cartilage — the cushion between bones — is what's causing their arthritis, but often, that's not the most important factor, as bone and connective tissue also deteriorate, Cimino explained. Cartilage cannot regenerate, but the bones themselves and the tendons holding them together can, he added.
Patients would not see any difference in images of their knees after the injections, but they have reported reduced pain and improved functioning in the smaller studies before the current trial, Cimino mentioned.
“This is definitely a repair at the cellular level,” he said.