This phase 1/2a trial will investigate the safety of an autologous mesenchymal stem cell transplant (AMSCT) to treat rheumatoid arthritis (RA). The main outcome measured will be the safety of AMSCT and response after 1 year. This trial is recruiting in Texas, United States.
Rheumatoid arthritis (RA) is a chronic (long-term) condition caused by inflammation. This leads to painful swelling in the joints and leads to disability over time. The standard treatment for RA are drugs to reduce inflammation. Some drugs become less effective over time. They are also associated with significant side effects. This is because these drugs can affect the whole body. Stem cell transplants are under investigation for the treatment of chronic diseases. One type of stem cell is mesenchymal stem cells (MSCs). MSCs are anti-inflammatory. Some studies show that delivering MSCs to the joint reduces inflammation in RA.
This trial will investigate the safety of AMSCT to treat RA. The main outcome will be the safety of AMSCT.
Who are they looking for?
This trial will recruit 15 patients with RA. Participants must be on a stable treatment regime for RA. Patients that are not currently treated for RA are also able to take part in the trial.
Patients cannot take part in the trial if they are receiving cancer treatment. Other exclusion criteria include uncontrolled illnesses such as hypertension, diabetes or liver and kidney disease, active infection (Hepatitis B, C, HIV, etc). Patients with a history of syphilis will also be excluded from the trial.
How will it work
Each patient will receive MSCs that are found in their own adipose (fat) tissue. To do this, a sample will be taken from patients and MSCs will be isolated in a laboratory. Once this is done, the MSCs will be delivered via an infusion. This will involve a single injection.
Patients will be followed up at 1, 3, 6 and 12 months for safety and effectiveness.