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

NCT04230902 | Unknown Phase 3

• 1 other identifier: BIO-2017-0440
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Keywords

mesenchymal stem cell; corticosteroid; adipose stem cell; MRI; pain; Knee

Outcome Measures

Primary Outcomes (2)

• Comparing the total pain score pre- and post-injection differences between the two arms

  The difference in total pain scores (using numerical rating scale) between the baseline visit (prior to injection) and 6 months after injection will be obtained for each arm. And these differences will be compared between Lipogems and Steroid arms using t-test to assess the effect of each injection type on pain severity

  6 months

• Comparing MOAKS pre-and post-injection differences between the two arms

  The difference in MOAKS values (MRI Osteoarthritis Knee Score) between the baseline visit (prior to injection) and 6 months after injection will be obtained for each arm. And these differences will be compared between Lipogems and Steroid arms using t-test to assess the anatomic effects of each injection type.

  6 months

Secondary Outcomes (6)

• Clinical outcomes-extension

  6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)

• Clinical outcomes-flexion

  6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)

• Clinical outcomes-stability

  6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)

• Cartilage thickness

  6 months (at 0weeks & 6months)

• Patient-based outcomes

  6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)

Study Arms (2)

Lipogems

EXPERIMENTAL

The cases assigned to this group will be injected intra-articularly with Lipogems®. The patients will undergo harvesting of their own adipose tissue for aMAT then this aMAT will be injected intra-articularly in the knee. It will be administered once at the baseline visit of the study.

Biological: Microfragmented Adipose Tissue Transplant

Steroid

ACTIVE COMPARATOR

The cases assigned to this group will be injected intra-articularly in the knee with corticosteroids. No extra preparation of any type is necessary in this case. It will be administered once at the baseline visit of the study.

Drug: Corticosteroid injection

Interventions

Microfragmented Adipose Tissue Transplant BIOLOGICAL

Autologous Microfragmented Adipose Tissue derived using Lipogems® Kit

Also known as: aMAT

Lipogems

Corticosteroid injection DRUG

intra-articular knee injection of corticosteroid

Also known as: steroid

Steroid

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are ≥ 45 years old
• Symptomatic knee OA defined as symptoms of knee pain and/or decreased range of motion (ROM)
• Classified radiographically as having Grade 2 or 3 Knee OA
• Failure of 3-months conservative management (NSAIDs and Physical therapy)

You may not qualify if:

• Patients \< 45 years old
• Pregnant or breastfeeding women
• Cancer patients
• Rheumatoid arthritis patients
• Patients having any autoimmune disease affecting the joint
• Patients who have had hyaluronic acid injection \<1 year ago
• Patients who have undergone lower extremity surgery or trauma on the same side
• Hypersensitivity to methylprednisolone (Depo-Medrol®)or any of its components, lidocaine/xylocaine or any of its components, and any of the ingredients of Lipogems® injection kit
• Patients with acute systemic or local infection
• Patients on anticoagulants (warfarin, coumadin, heparin, Xeralto, or Plavix)

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, 11-0236, Lebanon

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Adrenal Cortex Hormones; Steroids

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Said Saghieh, MD

  American University of Beirut Medical Center

  STUDY DIRECTOR

Central Study Contacts

Asdghig Der-Boghossian/study coordinator

CONTACT

+9611350000; ad24@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 18, 2020
• Study Start: March 4, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)