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NOT YET RECRUITING
NCT07157891
EARLY_PHASE1

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

Sponsor: University of the Punjab

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

30 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-12-10

Completion Date

2028-12-11

Last Updated

2025-09-05

Healthy Volunteers

No

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.