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

NCT06688318 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 932/VII/HREC/2024
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Knee

Keywords

osteoarthritis knee; Mesenchymal Stem Cell; conditioned media

Outcome Measures

Primary Outcomes (3)

• Functional Score 1. Knee Injury and Osteoarthritis Outcome Score (KOOS),

  The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

  2,4,6 Months

• Functional Score 2. Knee Society Score (KSS)

  The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

  2,4,6 Months

• Functional Score 3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score

  Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).

  2,4,6 Months

Secondary Outcomes (1)

• Radiographic Evaluation

  2,4,6 Months

Study Arms (1)

OA Knee

EXPERIMENTAL

Knee Intraarticular Conditioned Media Injection

Biological: Intra-articular secretome injection therapy

Interventions

Intra-articular secretome injection therapy BIOLOGICAL

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

OA Knee

Eligibility Criteria

• Age: 45 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia: lead

Study Sites (1)

Moewardi General Hospital

Surakarta, Central, 57126, Indonesia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Bintang S Bintang Soetjahjo, MD, PhD

  Dr. Moewardi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: April 3, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)