Adipose-derived MSCs After Enzymatic Digestion vs. Mechanically Fragmented Fat Transfer in Knee Osteoarthritis Treatment

NCT04675359 | Unknown Phase 4

• 1 other identifier: MSC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to compare the clinical effects of treatment of knee osteoarthritis using adipose tissue mesenchymal stromal cells obtained by an enzymatic method with the outcomes of the therapy with the mechanically fragmented adipose tissue. Identification and functional analysis of the regenerative capacity of MSCs derived from the adipose tissue depending on three variables (body weight, sex and age) will help to develop a targeted therapy for different groups of patients and will determine the effectiveness of both methods of treatment. An attempt was made to identify the groups of patients with the greatest regeneration potential of the adipose tissue, and thus indicate those with the most probable improvement of the joint condition.

Conditions

Knee Osteoarthritis; Chondropathy

Keywords

MSC; SVF; adipose tissue; knee osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Changes in patients reported outcome measures - Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). 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. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

  1,3,6 and 12 months after procedure

• Changes in flexibility of the knee joint

  Range of motion assessment by goniometer measurements

  1,3,6, and 12 months after procedure

Secondary Outcomes (2)

• Changes in X-ray imaging of the knee joint in a standing position (AP view)

  6 months and 1 year after procedure

• Changes in MRI with T-2 Mapping of the knee cartilage

  6 months and 1 year after procedure

Study Arms (2)

Enzymatic digestion group

ACTIVE COMPARATOR

A group treated with a stromal vascular fraction (SVF) with mesenchymal stromal cells (MSC) injection in the knee joint after an enzymatic digestion of autologous adipose tissue

Procedure: Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint

Mechanical fragmentation group

ACTIVE COMPARATOR

A group treated with a mechanically fragmented (using Lipogems device) autologous adipose tissue injection in the knee joint

Procedure: Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint

Interventions

Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint PROCEDURE

Injections of the two adipose tissue derived products containing MSCs into the knee joints with osteoarthritis

Also known as: Autologous mechanically fragmented adipose tissue injection into the knee joint using Lipogems device

Enzymatic digestion group; Mechanical fragmentation group

Eligibility Criteria

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

You may qualify if:

• Adults with symptomatic gonarthrosis diagnosed based on the X-ray, MRI and clinical examination, previously unsuccessfully treated (rehabilitation, NSAIDs, hyaluronic acid, platelet-rich plasma)
• Primary knee osteoarthritis
• Willingness and consent to participate in the study
• Readiness to attend control visits

You may not qualify if:

• Active chronic infection
• Metal implant made of a ferromagnetic material that will exclude the patient from magnetic resonance imaging
• Use of anticoagulants
• General and intra-articular use of steroids during the last year
• Pregnancy, breastfeeding
• Any autoimmune and rheumatic disease, or conditions that influence the accuracy of test results
• Taking drugs or cytostatic medications in the last 30 days
• Mental disorders, alcohol and drug addiction

Sponsors & Collaborators

• Medical University of Warsaw: lead

Related Publications (1)

• Krzesniak AM, Radzimowski K, Stolarczyk A. Comparison of the treatment results of knee osteoarthritis using adipose tissue mesenchymal stromal cells derived through enzymatic digestion and mechanically fragmented adipose tissue. Medicine (Baltimore). 2021 Mar 5;100(9):e24777. doi: 10.1097/MD.0000000000024777.

  PMID: 33655941 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Cartilage Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Artur Stolarczyk, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Krześniak, MD

CONTACT

+48600104793; anna.krzesniak@gmail.com

Artur Stolarczyk, MD, PhD

CONTACT

drstolarczyk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: July 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 1, 2023
• Last Updated: January 8, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share