Michael B. Gerhardt, MD - Orthopaedic Surgeon - Hip Specialist
Michael B. Gerhardt, MD - Orthopaedic Surgeon - Hip Specialist: (310) 829-2663
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JointStem study

JointStem Study (Stem Cell Study for Knee Pain)

Phase II, double-blind, randomized, controlled study with two arms to evaluate JointStem (an autologous stem cell line derived from your own fat tissue) as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 45 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). After the last subject completes 6-month visit (Visit 6) and the data management team confirms all data have no issue, the database will be locked and the blinding will be open for the statistical analysis. Subjects will then be scheduled for 9-month and 12-month follow-up visits (Visits 7 and 8).

Adipose (fat tissue) is harvested from the abdomen by liposuction. The adipose tissue is then processed to isolate stem cells. The stem cells are then expanded in a sterile lab setting over a number of days to create the Investigational Drug. The subjects are then randomized for knee injection between the Investigational Drug (Autologous Expanded Stem Cell Line) or Hyaluronic Acid.

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