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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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OA Knee

Knee Intraarticular Conditioned Media Injection

Group Type EXPERIMENTAL

Intra-articular secretome injection therapy

Intervention Type BIOLOGICAL

Intra-articular secretome injection therapy from hypoxic umbilical cord mesenchymal stem cell conditioned media

Interventions

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Intra-articular secretome injection therapy

Intra-articular secretome injection therapy from hypoxic umbilical cord mesenchymal stem cell conditioned media

Intervention Type BIOLOGICAL

Eligibility Criteria

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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,

Minimum Eligible Age

45 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No