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

NCT07255547 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: 23/2019EMEA-18060
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PRP; AD-SVF; knee arthroscopy; cartilage; adipose tissue; microfracture; stromal vascular fraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Knee pain assessment

  From preoperatively (baseline) until the end of the study, up to 60 months.

• Adverse events after the procedure

  Until the end of the study, up to 60 months.

• Other Patient-Reported Outcome Measures

  From preoperatively (baseline) to the end of the study, up to 60 months.

Study Arms (2)

PRP

ACTIVE COMPARATOR

In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection.

Procedure: Bone Marrow Stimulation; Drug: PRP injection

PRP + AD-SVF

EXPERIMENTAL

In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection.

Procedure: Bone Marrow Stimulation; Combination Product: stromal vascular fraction (SVF)

Interventions

Bone Marrow Stimulation PROCEDURE

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.

Also known as: knee arthroscopy, Steadman microfracture

PRP; PRP + AD-SVF

stromal vascular fraction (SVF) COMBINATION_PRODUCT

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.

Also known as: PRP injection

PRP + AD-SVF

PRP injection DRUG

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.

PRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi dell'Aquila: lead
• Arthrex GmbH: collaborator

Study Sites (1)

San Salvatore Hospital

L’Aquila, Abruzzo, 67100, Italy

Location

Related Publications (6)

• 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.

  PMID: 28619097 BACKGROUND

• 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.

  PMID: 36474791 BACKGROUND

• 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.

  PMID: 36788843 BACKGROUND

• 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.

  PMID: 37360195 BACKGROUND

• 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.

  PMID: 29525030 BACKGROUND

• 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.

  PMID: 26411978 BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: December 1, 2025
• Study Start: May 1, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication

Locations

IT (1)