Frequently Asked Questions

How many times will I need to come into the office?

You will need to come to the office for 6 visits from screening to completion of the study over the course of 6 months.

How will investigational treatment be administered?

Treatment will be by harvesting fat from your body and injecting cells into your joint.

What if I change my mind and no longer want to participate?

You may withdraw your consent at any time for any reason and drop out of the study. If you decide to withdraw, inform the study staff of your decision.

About Clinical Trials

Studies are underway to develop potential new treatments for knee pain from osteoarthritis. Clinical trials are research studies that measure safety and usefulness of new treatments in human volunteers.

You are the key to continuing research, treatment, and care. People who join clinical trials are the most important contributors in the development of new treatments.

About This Clinical Trial

This study will determine if the injection of stromal vascular fraction (SVF) cells (contains stem cells) derived from your fat will reduce pain due to osteoarthritis. A small amount of fat from your stomach or thigh will be processed and the SVF cells will be injected into your joint.

Participation in Clinical Trials

Your participation in a clinical trial is voluntary and should be based on your personal needs, interests and expectation.

Things to Consider before Volunteering:

Benefits:

• Ability to try new investigational medication and investigational treatments before it is widely available.
• Receive expert care for your condition
• The opportunity to contribute to the development of medical treatments for you and others like you.

Risks:

• Receiving an investigational treatment that may not work as planned
• Experience unpleasant side effects

What are the next steps?

Before you can participate, you must be “screened; to be sure you are right for the study and the study is right for you.

First, the study will be thoroughly explained and you will have an opportunity to ask questions. When you have a good understanding, you will be asked to sign a consent form.

Your Part

What happens during a clinical trial?

Study participants are given investigational treatment. Researchers continuously evaluate the condition of each participant. Participants may be asked if their symptoms are improving or if they are experiencing any side effects.

Do I have to meet certain participation requirements?

Yes, admission into a clinical trial is based on a rigid set of criteria. For the knee study, the following is a partial list of criteria:

• Diagnosed with osteoarthritis of the knee
• Male or female 40 to 75 years old
• Medically healthy