Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint

National Research and Innovation Agency (BRIN)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Osteoarthritis Knee

Treatments: Biological: Intra-articular secretome injection therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06688318

932/VII/HREC/2024

Details and patient eligibility

About

Osteoarthritis (OA) is a joint disorder that often occurs and causes disability. This disorder is characterized by an inflammatory reaction in the synovial joints accompanied by a gradual degeneration process in the articular cartilage and sub-chondral bone. Current research has discovered that stem cells produce conditioned media (secretome, extra vesicles, and exosomes) that have tissue regeneration, immunomodulation, anti-inflammatory, and anti-apoptotic capabilities. Research on conditioned media for umbilical cord mesenchymal stem cells is still at the in vivo stage in experimental animals. For this reason, this study aims to conduct clinical experimental research (translational study) in patients with knee joint OA who were given umbilical cord mesenchymal stem cell conditioned media via intra-articular injection.

Full description

The research was conducted as a clinical trial and translational study, involving a single group treated with intra-articular secretome injection therapy derived from hypoxic umbilical cord mesenchymal stem cell conditioned media.

This study explores the clinical application of conditioned media from umbilical cord mesenchymal stem cells for treating knee OA. Our preliminary clinical trial involves administering this conditioned media via intra-articular injections to patients, followed by assessments using functional scores and MRI with T2 mapping sequence. This approach aims to harness the therapeutic potential of MSC derivatives in a clinical setting, offering a novel and potentially less invasive alternative to conventional OA treatments. The aim of this study is to evaluate the effectiveness of intra-articular injections of conditioned media from umbilical cord mesenchymal stem cells in improving knee joint function and structural integrity in patients with osteoarthritis, as assessed by MRI and functional scoring.

Enrollment: 11 patients

Sex: All

Ages: 45+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 45 years
• primary knee joint OA Kellgrance-Lawrence grade 2 or 3,
• never had surgery or intra-articular injection before,

Exclusion criteria

• currently experiencing local infections and/or systemic infections,
• have a history of autoimmune disorders or immunodeficiency,
• have had surgery or injections on the knee joint,

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

OA Knee

Experimental group

Description:

Knee Intraarticular Conditioned Media Injection

Treatment:

Biological: Intra-articular secretome injection therapy