Osteo Arthritis Knee Clinical Trial
Official title:
Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Randomized Non Blind Controlled Clinical Trial
Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also
exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as
umbilical cord, bone marrow, and adipose tissue. The multipotent properties of MSCs make them
a promising option for the treatment of osteoarthritis (OA).
Bone marrow mesenchymal stem cells (BM-MSC) and adipose derived mesenchymal stem cells
(AD-MSC) have been used separately to treat OA. The aim of the present study will be to
compare in a randomized non blind controlled clinical trial 3 types of intra-articular
injections containing MSC populations obtained from two clinically relevant sources: BM-MSC,
AD-MSC and a combination of both BM-MSC and AD-MSC.
The aim of the present study will be to compare 3 types of intra-articular injections of MSC
populations obtained from two clinically relevant sources: injections containing BM-MSC or
AD-MSC or a combination of both BM-MSC,and AD-MSC in a randomized non blind clinical trial.
To assess the efficacy and safety of 3 kind of MSC injections in relation to pain, function
and quality of life in patients with knee OA.
A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to
receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive
BM-MSC, Group 3 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a
combination of BM-MSC and AD-MSC.
A randomized non blind clinical trial with active control. For this purpose, the random
number generator is 54, found on the RANDOM.ORG ® website (available at
https://www.random.org/integers/)
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