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Study on the Use of a Concentrated Growth Factor Preparation Kit for the Treatment of Knee Osteoarthritis

NCT06869200 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-03-19

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of an autologous platelet-rich concentrated growth factor (CGF) preparation kit for the treatment of knee osteoarthritis in patients diagnosed with this condition. The main question it aims to answer is:

Can the CGF preparation kit effectively improve symptoms and reduce pain in patients with knee osteoarthritis compared to a control intervention? Researchers will compare the CGF treatment group to a control group using platelet-rich plasma (PRP) to see if the CGF intervention results in greater improvements in knee function and pain relief.

Participants will:

Undergo three intra-articular injections of CGF or PRP into the knee joint at weekly intervals.

Complete assessments including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) for pain at specified intervals.

Be monitored for safety and potential adverse events throughout the study period.

Conditions

Interventions

DEVICE

Concentrated Growth Factor (CGF) Intra-articular Injection

Preparation Method: The CGF is prepared using an autologous platelet-rich preparation kit specifically designed to concentrate growth factors from the patient's own blood. The process involves a specialized centrifugation technique that yields a high concentration of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and other bioactive molecules. Rationale: This intervention leverages the body's natural healing response by utilizing autologous growth factors to enhance the repair of cartilage and other joint tissues affected by osteoarthritis. The high concentration of bioactive molecules in CGF is believed to provide a more potent therapeutic effect compared to other platelet-rich therapies.

DEVICE

Platelet-Rich Plasma (PRP) Intra-articular Injection

Preparation Method: The PRP is prepared using a disposable PRP preparation device that separates and concentrates platelets from the patient's blood. This process enriches the plasma with platelets and associated growth factors. Rationale: PRP has been widely used in clinical practice for its ability to promote tissue healing and reduce inflammation in osteoarthritis. It serves as an active comparator in this study, allowing for a direct comparison of the therapeutic efficacy and safety profile of CGF against a well-established treatment modality.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Shantou Central Hospital

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Guangdong Hongzhi Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2025-12-31
Completion
2026-02-28

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06869200 on ClinicalTrials.gov