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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Chondral Lesion
• Intervention / Treatment: Procedure: Bone Marrow Stimulation; Drug: PRP injection; Combination product: stromal vascular fraction (SVF)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Abruzzo
    • L’Aquila, Abruzzo, Italy, 67100
      • San Salvatore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• knee pain and functional limitation for at least three months, monocompartmental chondral lesion < 2 cm2, age over 18, and BMI between 18.5 and 30

Exclusion Criteria:

• previous major surgery on the same knee, concomitant chondral lesions in other knee compartments, being diagnosed with knee or hip osteoarthritis, knee instability, flexion deficit > 20° or extension deficit >15°, genu valgum or genu varum > 20°, patients with Hb values < 11 g/dL or platelet < 150000/µL, patients in therapy with antiaggregants or anticoagulants or immunosuppressive agents, pregnancy, and the following comorbidities: hematological/neurologic/metabolic/rheumatic diseases, neoplastic disorders or history of local infections.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRP; In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection.	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.; Other Names: knee arthroscopy; Steadman microfracture; 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.
Experimental: PRP + AD-SVF; In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection.	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.; Other Names: knee arthroscopy; Steadman microfracture; 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.; Other Names: PRP injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in knee clinical function questionnaire (KOOS)	Knee Injury Osteoarthritis Outcome Score is a self-administered questionnaire and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. The resulting scores are then transformed to a scale from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problems. The scores on this scale represent the percentage of the total possible score that the person achieved.	From preoperatively (baseline) until the end of the study, up to 60 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee pain assessment	Pain intensity was measured using the Visual Analogue Scale (VAS).	From preoperatively (baseline) until the end of the study, up to 60 months.
Adverse events after the procedure	Adverse events such as knee swelling and pain with longer recovery time	Until the end of the study, up to 60 months.
Other Patient-Reported Outcome Measures	Overall physical and mental health-related quality of life was assessed with the 12-item Short Form Survey (SF-12). The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete.Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Additionally, the IKDC questionnaire was used to measure knee symptoms, functional limitations, and sports activity. An ordinal scoring system is used to assign a score of 0 to responses that signify the lowest level of function or the highest level of symptoms for each item. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a 0-100 scale. Higher scores indicate higher levels of function and lower levels of symptoms.	From preoperatively (baseline) to the end of the study, up to 60 months.

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Aquila
• Collaborators: Arthrex GmbH

Publications and helpful links

General Publications

• Bora P, Majumdar AS. Adipose tissue-derived stromal vascular fraction in regenerative medicine: a brief review on biology and translation. Stem Cell Res Ther. 2017 Jun 15;8(1):145. doi: 10.1186/s13287-017-0598-y.
• Prodromidis AD, Charalambous CP, Moran E, Venkatesh R, Pandit H. The role of Platelet-Rich Plasma (PRP) intraarticular injections in restoring articular cartilage of osteoarthritic knees. A systematic review and meta-analysis. Osteoarthr Cartil Open. 2022 Nov 5;4(4):100318. doi: 10.1016/j.ocarto.2022.100318. eCollection 2022 Dec.
• Srinivasan V, Ethiraj P, Agarawal S, H S A, Parmanantham M. Comparison of Various Modalities in the Treatment of Early Knee Osteoarthritis: An Unsolved Controversy. Cureus. 2023 Jan 11;15(1):e33630. doi: 10.7759/cureus.33630. eCollection 2023 Jan.
• Cong B, Sun T, Zhao Y, Chen M. Current and Novel Therapeutics for Articular Cartilage Repair and Regeneration. Ther Clin Risk Manag. 2023 Jun 20;19:485-502. doi: 10.2147/TCRM.S410277. eCollection 2023.
• Welton KL, Logterman S, Bartley JH, Vidal AF, McCarty EC. Knee Cartilage Repair and Restoration: Common Problems and Solutions. Clin Sports Med. 2018 Apr;37(2):307-330. doi: 10.1016/j.csm.2017.12.008.
• Mirza MZ, Swenson RD, Lynch SA. Knee cartilage defect: marrow stimulating techniques. Curr Rev Musculoskelet Med. 2015 Dec;8(4):451-6. doi: 10.1007/s12178-015-9303-x.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 27, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: cartilage; adipose tissue; stromal vascular fraction; PRP; knee arthroscopy; microfracture; AD-SVF
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress
• Other Study ID Numbers: 23/2019; EMEA-18060 (Other Grant/Funding Number: Arthrex GmbH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: only IPD used in the results publication
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes