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Effects of α MAT Versus Steroid Injection in Knee Osteoarthritis (STα MAT-knee Study)

NCT04230902 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-01-18

No results posted yet for this study

Summary

Knee Osteoarthritis (OA) is a common degenerative knee condition of the knee which is treated symptomatically. Knee cartilage tissue has little regenerative ability With the developments in regenerative medicine, stem cells might also be used in knee OA. Recently, adipose tissue has been identified as means for autologous mesenchymal stem cells (aMAT) using non-enzymatic method. Lipogems® is FDA-approved closed-system and directly producing ready-to-use aMAT. Some observational studies showed its potential in knee chondropathy. With no clinical trial done as yet, the investigators will hereby study the comparative efficacy of corticosteroid (current practice) versus Lipogems® in patients with knee OA. The knee MRI changes, clinical and patient-based outcomes will compared between baseline and throughout till 6 months after treatment. This study aims to show the comparative efficacy of Lipogems® as compared to corticosteroid in knee OA patients and to demonstrate its cartilage regeneration potential, which will ultimately deter surgery.

Conditions

Interventions

BIOLOGICAL

Microfragmented Adipose Tissue Transplant

Autologous Microfragmented Adipose Tissue derived using Lipogems® Kit

DRUG

Corticosteroid injection

intra-articular knee injection of corticosteroid

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Said Saghieh, MD · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Lebanon

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04230902 on ClinicalTrials.gov