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

N

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)

11 participants in 1 patient group

OA Knee
Experimental group
Description:
Knee Intraarticular Conditioned Media Injection
Treatment:
Biological: Intra-articular secretome injection therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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