Duke logo

Miles Study of Stem Cell Injections for Knee OA - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if giving a stem cell shot in the knee works as well or better than giving a steroid shot to treat arthritis.

What is the Condition Being Studied?

Osteoarthritis of the Knee

Who Can Participate in the Study?

Adults who:
- Are ages 40-70 years old
- Have moderate knee osteoarthritis
- Fit other health criteria
- Can have a MRI
- Are not pregnant

Age Group
Adults

What is Involved?

If you choose to join this study you will:
- Be randomly chosen (like drawing numbers out of a hat) to have one of 3 procedures to get the stem cells:
-- Bone marrow procedure
-- Liposuction procedure
-- Donor stem cells

You will then be randomly chosen (like the flip of a coin) to have:
- The stem cells
OR
- A steroid shot in your knee

You will:
- Not be told which shot you are getting
- Have a 75% chance of getting the stem cell shot
- Have your knee looked at by the doctor and have your overall health checked
- Have 3 MRIs
- Be asked to answer health-related questions
- Have blood collected for lab testing
- Be asked to return for 6 visits and a phone call over the course of a year

Study Details

Full Title
Randomized multicenter phase 3 single-blind trial comparing the efficacy of corticosteroid control to mesenchymal stem cell preparations from autologous bone marrow concentrate (BMAC), adipose derived stem cells in the form of Stromal Vascular Fraction (SVF), and third party human mesenchymal stem cells manufactured from umbilical cord tissue for the treatment of unilateral Knee Osteoarthritis (OA).
Principal Investigator
Sports Medicine Specialist
Protocol Number
IRB:PRO00101491
NCT:NCT03818737
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698