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

NCT ID: NCT04675359

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-12-01

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.

Detailed Description

Based on the calculation of the sample size using power analysis of the test, investigators plan to include 100 adults with primary knee osteoarthritis in this study. The patients will undergo lipoaspiration under sterile conditions of the operating theatre, the collected lipoaspirates will be further processed - enzymatically with the use of collagenase or mechanically using the Lipogems system. After collection, lipoaspirates will be immediately transferred to the laboratory of the Department of Regenerative Medicine with a tissue and cells bank in Warsaw, and the preparations will be administered to the patients' knee joints in the operating room under ultrasound control.

The Lipogems system is defined as a minimal tissue manipulation system. In contrast, the administration of preparations produced using an enzymatic method requires advanced actions.

Lipoaspiration will be performed using blind cannulas and vacuum syringes introduced through the abdominal wall with a three-millimetre incision on the skin after previous injection to the adipose tissue with modified Klein's solution (500 ml of saline solution, 1 ml of adrenaline, 40 ml of 2% lignocaine), which makes the collection easier. 10 ml of the collected adipose tissue will be used to examine the samples after previous gradient drainage from Klein's solution. Immediately after collection, the samples will be sent to the laboratory for analysis (cell count testing, culture, phenotype identification, analysis by flow cytometry).

The patients will be monitored in the hospital outpatient clinic for one year after the procedure; the control visits will take place: after 2 and 6 weeks, then after 3 and 6 months and after a year. A physical examination and the assessment using the KOOS questionnaire will be performed. Before the procedure and after one year, an X-ray and MRI with T-2 Mapping will be carried out in order to evaluate the condition of the cartilage.

Conditions

Knee Osteoarthritis; Chondropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Enzymatic digestion group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

Mechanical fragmentation group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

Interventions

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

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

Intervention Type: PROCEDURE

Other Intervention Names

Autologous mechanically fragmented adipose tissue injection into the knee joint using Lipogems device

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Artur Stolarczyk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Central Contacts

Anna Krześniak, MD

Role: CONTACT

anna.krzesniak@gmail.com

+48600104793

Artur Stolarczyk, MD, PhD

Role: CONTACT

drstolarczyk@gmail.com

References

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.

Reference Type: DERIVED

PMID: 33655941 (View on PubMed)

Other Identifiers

MSC

Identifier Type: -

Identifier Source: org_study_id