Trial | NCT04351932  Report issue

Title

Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis
Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Randomized Non Blind Controlled Clinical Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    54
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/)
Study Started
Jun 07
2020
Anticipated
Primary Completion
Jun 07
2021
Anticipated
Study Completion
Sep 07
2021
Anticipated
Last Update
Apr 17
2020

Biological bone marrow mesenchymal stem cells

intrarticular bone marrow mesenchymal stem cells injection

Biological Adipose Mesenchymal stem cells

intrarticular adipose mesenchymal stem cells injection

Biological bone marrow & adipose mesenchymal stem cells injection [bone marrow derived mesenchymal stem cells, allogeneic adipose derived mesenchymal stem cell]

intrarticular bone marrow and adipose stem cells injection.

bone marrow mesenchymal stem cell Active Comparator

Bone marrow mesenchymal stem cells 10 cc by intra articular injection once

adipose mesenchymal stem cells Active Comparator

Stromal vascular factor from adipose mesenchymal stem cells 10 cc by intra articular injection once

Bone marrow and Adipose mesenchymal stem cells Active Comparator

Bone marrow and Stromal vascular factor from adipose mesenchymal stem cells 5 cc each one, by intra articular injection once.

Criteria 

Inclusion Criteria:

Patients aged 18 to 70 years, with grade II and III knee OA, according to the Ahlbäck classification will be included.
Minimal VAS pain score of 4.
Chronic knee pain of mechanical origin.
All patients who sign a specially prepared informed consent for this clinical trial.

Exclusion Criteria:

Varus or valgus knee mal alignment superior to 10°.
OA grade IV according Ahlbäck classification.
Bone marrow cancer like lymphoma.
Severe anemia.
Active infections.
Pregnant patients.
Inmune diseases such as Rheumatoid arthritis, gout or pseudogout arthritis, psoriasis.
Bone diseases such as Kahler and Paget.
Corticoesteroid and hyaluronic injections within the last 3 months.
Knee surgery in the last 6 months.
No Results Posted