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

NCT07157891 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-05

No results posted yet for this study

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

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • University of the Punjab

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2027-12-11
Completion
2028-12-11

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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 NCT07157891 on ClinicalTrials.gov