NCT04351932

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Universidad Catolica Santiago de Guayaquil · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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/)

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
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	intrarticular bone marrow and adipose stem cells injection.

Timeline

• Start date: 2020-06-07
• Primary completion: 2021-06-07
• Completion: 2021-09-07
• First posted: 2020-04-17
• Last updated: 2020-04-17

Locations

1 site across 1 country: Ecuador