Clinical Efficacy of Exosome in Degenerative Meniscal Injury (KNEEXO)

March 3, 2022 updated by: Ayla Eker Sariboyaci, Eskisehir Osmangazi University

A Phase II Trial to Investigate Clinical Efficacy of Autologous Synovial Fluid Mesenchymal Stem Cell-Derived Exosome Application in Patients With Degenerative Meniscal Injury

Comparison of intra-articular administration of synovial fluid-derived mesenchymal stem cells-derived exosomes with synovial fluid-derived mesenchymal stem cells on the same patient.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Mesenchymal stem cell-derived exosomes will be developed and patented as an advanced technology platform as an autologous treatment protocol to repair damaged cartilage tissue. The fact that this treatment is obtained from an autologous source will significantly contribute to the literature in the field of personalized therapy (personalized medicine) and will pave the way for discoveries. Experiences from clinical trials may guide the use of MSC exosomes in other tissue and cell damaged pathologies and immune pathologies or chronic inflammatory diseases.

This study was supported by a grant (1004, 20AG031) from The Scientific and Technological Research Council of Turkey (TUBITAK).

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Eskisehir, Turkey, 26040
        • Recruiting
        • Eskisehir Osmangazi University
        • Contact:
        • Principal Investigator:
          • Ulukan Inan, Prof.Dr.
        • Sub-Investigator:
          • Ayla Eker Sariboyaci, AssocProfDr
        • Sub-Investigator:
          • Onur Uysal, AssocProfDr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Accepting the Informed Consent Form
  • Degenerative meniscus damage grade 1, 2 or 3 on MRI in both right and left knees, and also the patient does not want surgical treatment
  • Patients with the same degenerative meniscus grade in both knees
  • Patients with ongoing pain
  • Patients without a history of malignancy
  • Absence of signs of unstable meniscus tear such as snagging or locking
  • Patients with stage 0, 1 or 2 gonarthrosis according to Kellgren-Lawrence gonarthrosis staging
  • Patients without lower extremity malalignment

Exclusion Criteria:

  • Patients whose treatment method was explained and who did not accept the method
  • Patients outside the working-age range
  • Congenital lesion
  • Patients requiring surgical treatment (e.g. bucket handle tear and locked knee)
  • Active inflammatory or connective tissue disease is thought to affect the patient's pain (eg lupus, rheumatoid arthritis, fibromyalgia)
  • Local or systemic infection
  • Pregnant or breastfeeding women
  • Active endocrine disorder that may affect the assessment of patient's pain (eg, hypothyroidism, diabetes)
  • Active neurological disorder that may affect the assessment of the patient's pain (eg, peripheral neuropathy, multiple sclerosis)
  • Active heart disease
  • Presence of a pacemaker
  • Conditions where MR-I is contraindicated
  • Patients with stage 3 or 4 gonarthrosis according to Kellgren-Lawrence gonarthrosis staging
  • Patients with lower extremity malalignment
  • Patients with signs of unstable meniscus tear such as snagging or locking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SF-MSC-EX Treatment Group (Experimental group's left knees)
The left knee will receive 1 million cells/kg SF-MSC-EX (Synovial fluid mesenchymal stem cell-derived exosome) by intra-articular injection method.
Drug: SF-MSC-EX
Intra-articular administration of synovial fluid-derived mesenchymal stem cells-derived exosomes
Other Names:
  • Intraarticular Exosome Treatment
Experimental: SF-MSC Treatment Group (Experimental group's right knees)
The right knee will receive 1 million cells/kg SF-MSC (Synovial fluid-derived mesenchymal stem cell) by intra-articular injection method.
Drug: SF-MSC
Intra-articular administration of synovial fluid-derived mesenchymal stem cells
Other Names:
  • Intraarticular Stem Cell Treatment
No Intervention: Control Group
Participants who received no treatment were defined as the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Knee Functions
Time Frame: Up to 12th months
The functional evaluation of the participants will be evaluated on the Tegner-Lysholm knee scoring scale. In Tegner-Lysholm knee scoring, examinations for the knee joint (Limp, support, pain, instability, locking, swelling, stair-climbing, and squatting) will be evaluated, and a maximum of 100 and a minimum of 0 points will be given. According to the evaluation, <65 points are interpreted as bad, 65-83 points as fair, 84-90 points as good, >90 points as excellent. Scores will be recorded by being examined before treatment and at the 6th, and 12th months after treatment. Knee functions of the control group will be evaluated simultaneously, and the effects of treatments on knee function will be determined.
Up to 12th months
Evaluation of Physical Activity
Time Frame: Up to 12th months
The physical activity evaluation of the participants will be evaluated with the IPAQ (international physical activity questionnaire) short form. IPAQ short form will be evaluated and recorded before treatment and at the 6th, and 12th months after treatment. The control group's physical activity will be evaluated simultaneously, and the effects of treatments on physical activity will be determined.
Up to 12th months
Evaluation of Pain
Time Frame: Up to 12th months
Pain assessment of the participants will be evaluated with VAS (Visual analog scale). The VAS will be evaluated and recorded before treatment and at the 6th, and 12th months after treatment. The physical activity of the control group will be evaluated simultaneously, and the effects of treatments on pain will be determined.
Up to 12th months
Evaluation of Radiological Images
Time Frame: Up to 12th months
Participants will receive knee x-ray imaging and knee magnetic resonance imaging before treatment. The same radiological imaging will be performed at the 6th and 12th months after the treatment. At the same time, the same radiological imaging will be performed on the control group, and the effects of treatments on radiological imaging will be evaluated.
Up to 12th months
Evaluation of Cytokine Levels and Cytokine Genes Analyzes
Time Frame: Up to 12th months
Before treatment and at the 6th and 12th months after treatment, cytokine levels (IL-10, IL-6, TNF-α, IL-8, IL-1β, IFN-ɣ, IL-2, IL-4, IL-13, MCP-1, VEGF) and gene analyzes (IL-10, IL-6, TNF-α, IL-8, IL-1β, IFN-ɣ, IL-2, IL-4, IL-13, MCP-1, IL-1ra, MIP-1b, CTGF, TGFβ3, BMP-2, BMP-4, IGF-1, IGF-2, PDGF, EGF, and VEGF genes) will be checked in the samples taken from the synovial fluid and blood. Samples will be taken from the control group along with the treatment group. In this way, the effects of treatments on cytokine levels will be evaluated.
Up to 12th months
Evaluation of Edema
Time Frame: Up to 12th months
Edema in both knees will be measured using a tape measure by marking the midpoints of both patellae. Pre-treatment measurements will be recorded. Measurements of both knees will be recorded at 6 months and 12 months after treatment. The knees of the patients not receiving treatment will be measured simultaneously, and the changes will be compared.
Up to 12th months
Evaluation of Knee Joint Range of Motion
Time Frame: Up to 12th months
The range of motion of both knees will be measured using the "Baseline Digital Absolute+Axis Goniometer." Knee extension measurements will be made with the patient in the supine position and flexion in the prone position. Pre-treatment measurements will be recorded. Post-treatment 6th and 12th-month measurements will also be recorded. Measurements of patients not receiving treatment will be recorded simultaneously, and changes will be compared.
Up to 12th months
Monitoring of treatment-related complications
Time Frame: Up to 12th months
Adverse effects and complications will be observed in the treatment group, except for the expected local reactions (redness, swelling, bruising, etc.) after the application.
Up to 12th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Study Chair: Ayla Eker Sarıboyacı, AssocProfDr., Cell Therapy and Stem Cell Production Application and Research Center (ESTEM)
  • Study Director: Onur Uysal, AssocProfDr., Cell Therapy and Stem Cell Production Application and Research Center (ESTEM)
  • Principal Investigator: Ulukan İnan, ProfDr., Eskisehir Osmangazi University Faculty of Medicine Department of Orthopedy and Traumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56733164/203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results will be reported after the completion of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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