Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis

Universidad Catolica Santiago de Guayaquil

Status and phase: Unknown; Phase 3

Conditions: Osteo Arthritis Knee

Treatments: Biological: Adipose Mesenchymal stem cells; Biological: bone marrow mesenchymal stem cells; Biological: bone marrow & adipose mesenchymal stem cells injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04351932

UCSantiagodeGuayaquil001

Details and patient eligibility

About

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.

Full description

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/)

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 3 patient groups

bone marrow mesenchymal stem cell

Active Comparator group

Description:

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

Treatment:

Biological: bone marrow mesenchymal stem cells

adipose mesenchymal stem cells

Active Comparator group

Description:

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

Treatment:

Biological: Adipose Mesenchymal stem cells

Bone marrow and Adipose mesenchymal stem cells

Active Comparator group

Description:

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

Treatment:

Biological: bone marrow & adipose mesenchymal stem cells injection