Clinical trial NCT06688318: Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint
Official title: Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint: A Clinical Study of Functional Score and Magnetic Resonance Imaging Evaluation Using CartiGram
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis Knee
Keywords: osteoarthritis knee
Mesenchymal Stem Cell
conditioned media
Lead sponsor: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Sponsor class: OTHER_GOV
First posted: 2024-11-14
Enrollment: 11
Sex: ALL
Minimum age (years): 45
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Functional Score 1. Knee Injury and Osteoarthritis Outcome Score (KOOS),
timeFrame: 2,4,6 Months
measure: Functional Score 2. Knee Society Score (KSS)
timeFrame: 2,4,6 Months
measure: Functional Score 3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score
timeFrame: 2,4,6 Months
Secondary outcomes:
measure: Radiographic Evaluation
timeFrame: 2,4,6 Months
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: Moewardi General Hospital
state: Central
Study officials:
affiliation: Dr. Moewardi Hospital
name: Bintang S Bintang Soetjahjo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: