NCT07255547

PRP vs AD-SVF in Addition to Marrow Stimulation for Knee Chondral Lesion

Arthrosocpic Treatment of Knee Chondral Lesions: Clinical, MRI and Histologic Comparison Between the Use of PRP vs ADSCs in Addition to Marrow Stimulation Techniques

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Università degli Studi dell'Aquila · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if PRP and adipose-derived stem cells (AD-SVF) enhance healing after knee microfracture for chondral lesions. It will also learn about the safety of the procedure. The main questions it aims to answer are: Do PRP and AD-SVF get better results than PRP alone in patients undergoing arthroscopic microfracture for knee monocompartmental cartilage injuries? What medical problems do participants have when taking drug ABC? Researchers will compare PRP + AD-SVF to PRP alone to see if PRP + AD-SVF work better to treat knee cartilage injuries. Participants will: Undergo knee microfracture and biologics injections at the end of the arthroscopic procedure (PRP+AD-SVF vs PRP). Visit the clinic for checkups and tests at baseline and at 3, 6, 12 months post-treatment, and then annually.

Conditions

• Knee Chondral Lesion

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Stimulation	All patients underwent an arthroscopic procedure (that further confirmed the preoperative diagnosis; i.e. monocompartmental chondral lesion - Outerbridge grade IV) including a concomitant bone marrow stimulation technique (microfracture). According to the technique described by Steadman, the cartilaginous lesion underwent preliminary debridement to remove the damaged cartilage and form a stable edge of healthy tissue and subsequent microfracture with an arthroscopic pick to stimulate the subchondral unit regenerative response.
COMBINATION_PRODUCT	stromal vascular fraction (SVF)	After bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections.
DRUG	PRP injection	After bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections.

Timeline

• Start date: 2019-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study