Investigating the Safety and Regenerative Potential of MSC-Derived Secretome Combined With PRGF in Knee Osteoarthritis

Обзор

This Phase I/II randomized clinical trial investigates the safety, feasibility, and early regenerative potential of intra-articular administration of mesenchymal stem cell (MSC)-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with knee osteoarthritis (KOA). The study aims to assess whether this cell-free, biologically enriched therapeutic combination can reduce pain, improve joint function, and promote cartilage repair.

Подробное описание

Osteoarthritis (OA) is a chronic, degenerative joint disease characterized by progressive cartilage degradation, joint space narrowing, subchondral bone remodeling, inflammation, and pain that ultimately impair mobility and quality of life. Current treatment options, including analgesics, corticosteroids, and surgery, offer symptomatic relief but do not halt disease progression or restore joint tissue integrity.

Recent advancements in regenerative medicine have highlighted the therapeutic potential of mesenchymal stem cells (MSCs), particularly adipose-derived MSCs (AD-MSCs) and umbilical cord- derived MSCs (UC-MSCs), due to their robust paracrine activity. Rather than relying solely on cell engraftment, MSCs exert their therapeutic effects primarily through their secretome. These are complex mixtures of cytokines, growth factors, extracellular vesicles (EVs), and exosomes. This secretome can promote cartilage repair, reduce inflammation, and modulate immune responses, all without the risks associated with live cell transplantation.

This prospective, interventional study aims to evaluate the safety, tolerability, and early efficacy of intra-articular administration of MSC-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with mild to moderate symptomatic knee osteoarthritis (Kellgren-Lawrence grade II-III).The secretome will be collected from culture of human ADMSCs and UCMSCs grown in GMP-compliant labs, characterized for sterility, protein content, particle size, and bioactivity prior to administration.

Primary outcomes will include pain reduction assessment and any adverse events via Visual Analog Scale (VAS) and WOMAC index. If there will be adverse events, they will also be checked. Secondary outcomes will include functional improvement, cartilage regeneration (X-ray or MRI assessment), and changes in synovial inflammatory biomarkers (e.g., IL-1β, TNF-α, IL-6, MMP-13).

This study hypothesizes that the cell-free combination of MSC secretome and PRGF will offer regenerative benefits in knee OA, potentially improving joint function and structure while minimizing the risks associated with live cell therapies. Findings from this trial will inform the design of future large-scale studies and support the development of secretome-based regenerative therapies for osteoarthritis.

Вмешательства

• Биопрепарат MSC-Derived Secretome
  The secretome will be collected from cultured MSCs under sterile, GMP-compliant conditions and concentrated to retain bioactive molecules. It will be injected into the affected knee under ultrasound guidance.
• Биопрепарат MSC-Derived Secretome + Autologous PRGF
  MSC-derived secretome will be collected from mesenchymal stem cell cultures under sterile, GMP-compliant conditions. Autologous PRP will be prepared from the participant's own peripheral blood using a standardized single-spin centrifugation method and combined with 10% calcium chloride to activate growth factors. Both components will be mixed and administered into the affected joint under ultrasound guidance.

Первичные конечные точки

• Change in Knee Pain (VAS Score) Change in WOMAC Score Adverse Events (Safety Monitoring) [Срок оценки: From enrollment through the treatment period (Day 0 to Day 14); and at follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment.]

Критерии участия

Критерии включения

• Following is the inclusion criteria for the enrolment of patients affected with damaged cartilage in this study:

• Diagnosed with primary OA in one or both knees based on American College of Rheumatology criteria
• Grade I and II Arthritis
• Joint pain ≥ 20mm measured by visual analogue scale
• Age ranges from 30-55 years of age
• BMI 27.12 ± 4.38
• Patients with no previous surgical interventions to lower limb
• Willing to participate in the study

Критерии исключения

• • Secondary OA due to trauma, infection, rheumatoid arthritis, congenital disease or other inflammatory disorders of the knee

• Diagnosed with a systemic autoimmune disorder, immunodeficiency or coagulation disorder
• Had history of malignancy
• History of allergy or allergic constitution
• Pregnant or breastfeeding women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07157891 · MSCSEC-OA-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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