Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-31

Brief Summary

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The goal of this observational study is to evaluate the combined single-step approach with biomaterials and mesenchymal stem/stromal cells in the treatment of knee articular surface lesions. The clinical analysis of the treatment outcomes, regarding postoperative improvements and safety, is going to be accompanied with laboratory analysis of the intraoperatively applied cellular products.

The main hypothesis are: (1) such combined single-step procedure significantly improves patients' functioning and quality of life; (2) this therapeutic approach is safe; (3) cellular parameters of the applied filtered bone marrow aspirate (fBMA) impact treatment outcomes, among other potential predictors.

Researchers will compare subjective (questionnaire) and objective (clinical examination) status of patients before and after the operation, record any potential complications and perform regression analysis to assess the influence of potential predictors on postoperative improvements.

Detailed Description

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Conditions

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Knee Injuries Cartilage Injury Osteochondral Defect

Keywords

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Biomaterials Mesenchymal stem/stromal cells Bone marrow aspirate Cartilage Osteochondral lesion Knee

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Biomaterials augmented with mesenchymal stem/stromal cells

Combined single-step procedure of treating knee articular surface lesions with biomaterials (scaffolds) and mesenchymal stem cells (filtered bone marrow aspirate concentrate)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* informed consent
* patients treated with combined single-step procedure (scaffold and fBMA) for knee articular surface lesions, between January 2013 and December 2020
* symptomatic knee articular surface lesions (International cartilage repair society (ICRS) grades 3-4, size ≥ 1.5 cm2) unresponsive to conservative treatment,
* only mild concomitant osteoarthritis (Kellgren-Lawrence grades 1-2)

Exclusion Criteria

* patients that refuse to participate in the study
* non responders to the invitation to answer PROMs at the follow-up
* associated medical conditions (inflammatory, metabolic, neoplastic, etc.) that could directly handicap the musculoskeletal system or indirectly impact the quality of life

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matic Kolar, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

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University medical centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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Kolar M, Veber M, Girandon L, Drobnic M. A Biomimetic Osteochondral Scaffold Augmented With Filtered Bone Marrow Aspirate for the Treatment of Joint Surface Lesions in the Knee. Am J Sports Med. 2024 Jun;52(7):1826-1833. doi: 10.1177/03635465241247788. Epub 2024 May 20.

Reference Type DERIVED

PMID: 38767159 (View on PubMed)

Other Identifiers

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University Medical Centre

Identifier Type: -

Identifier Source: org_study_id