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

NCT07157891 | Not Yet Recruiting Early Phase 1

• 1 other identifier: MSCSEC-OA-001
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis (OA); Knee Injury; Cartilage Degeneration

Keywords

Mesenchymal Stem Cell Secretome; Plasma Rich in Growth Factors (PRGF); Platelet-Rich Plasma (PRP); Knee Osteoarthritis; Intra-articular Injection; Cell-free Therapy; Regenerative Medicine

Outcome Measures

Primary Outcomes (1)

• Change in Knee Pain (VAS Score) Change in WOMAC Score Adverse Events (Safety Monitoring)

  Participants are evaluated for change in pain intensity using the Visual Analog Scale (VAS). Best outcome: pain score significantly reduced. If any Worst outcome: no change or increased pain. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be used to assess pain, stiffness, and physical function. Best outcome: improved total WOMAC score. Any local or systemic adverse events related to intra-articular administration of MSC secretome + PRP will be monitored and documented. Events will be categorized by type, severity, and relation to treatment.

  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.

Other Outcomes (1)

• Change in Cartilage Thickness (MRI) Synovial Fluid Biomarkers Patient Global Assessment

  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.

Study Arms (2)

MSC-Derived Secretome

EXPERIMENTAL

MSC-derived secretome will be administered as intra-articular injections under ultrasound guidance to the affected knee. Injection will be given twice, each after 6 months. Each injection will consist of 2 mL of concentrated MSC-derived secretome.

Biological: MSC-Derived Secretome

MSC-Derived Secretome + Autologous PRGF

EXPERIMENTAL

MSC-derived secretome combined with autologous plasma-rich in growth factors plasma (PRGF) will be administered as intra-articular injections under ultrasound guidance to the affected knee. Injections will be given twice, each after 6 months. Each injection will consist of 2 mL of concentrated MSC-derived secretome and 1 mL of autologous PRGF, totaling 3 mL per dose.

Biological: MSC-Derived Secretome + Autologous PRGF

Interventions

MSC-Derived Secretome BIOLOGICAL

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.

Also known as: Conditioned Medium, MSC Secretome Therapy

MSC-Derived Secretome

MSC-Derived Secretome + Autologous PRGF BIOLOGICAL

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.

Also known as: MSC-Secretome/PRGF Combined Therapy

MSC-Derived Secretome + Autologous PRGF

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Punjab: lead
• Centre of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore.: collaborator

MeSH Terms

Conditions

Osteoarthritis; Knee Injuries; Osteoarthritis, Knee

Interventions

Culture Media, Conditioned

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Culture Media; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 11, 2027
• Study Completion (Estimated): December 11, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08