This trial is looking at the safety and effectiveness of using an injection of stem cells to improve the symptoms of benign prostatic hyperplasia (BPH). The main outcome to be measured is the improvements in urinary symptoms and the appearance of side effects. This study is taking place in Montana, USA.
Benign prostatic hyperplasia (BPH) is a non-cancerous growth of the prostate gland. An enlarged prostate can affect urinary function and have a negative impact on quality of life. BPH can cause a lot of inflammation around the urinary organs and affects their function this way. Treatments for BPH may include medication or surgery to remove excess prostate tissue.
Stem cell therapy involves injecting cells (harvested from the patient) which can grow and repair tissue that has been damaged. Stem cells can be injected with stromal cells. Stromal cells are a special type of cell which surround other tissues or organs. They help control and ease inflammation.
This trial is testing the safety and effectiveness of stem/stromal cells injection for treating symptoms of BPH. The main outcome to be measured in this study is an improvement in symptoms and side effects to the therapy.
Who are they looking for?
200 participants are required for this trial. Participants should have a history of BPH for at least 1 year. They should also have severe nocturia (more than one urination at nighttime). A prostate-specific antigen (PSA) level between 4 and 10 ng/ mL should also be present. Participants should have been checked and confirmed as being prostate cancer free.
Participants will not be included if they have a medical condition or using prescription medication which may endanger them. Patients should not have severe urinary retention.
How will it work
Participants will be divided into 3 groups. Each group will receive an injection of a different form of the stem and stromal cells. Participants will have visits straight after the treatment, at 1 month after, at 6 months after and at 1 year after. Participants will be assessed at these visits for complications, for changes in urinary symptoms. They will also be assessed for BPH severity.