← Back to Search

BMAC for Osteoarthritis

N/A

Recruiting

Led By Brian J Cole, MD, MBA

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is greater than 18 years old

Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy

Must not have

History of rheumatoid arthritis or other autoimmune disorder

Concomitant surgery such as ligament surgery or cartilage repair or restoration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year, 2 years

Summary

This trial will compare the outcomes of patients who receive BMAC after meniscectomy to those who don't, in terms of symptoms, physical examination, MRI, radiographs, and synovial fluid analysis. The hypothesis is that BMAC will improve outcomes.

Who is the study for?

This trial is for adults over 18 with a painful meniscal tear confirmed by MRI and surgery, who need a meniscectomy. They must have mild to moderate osteoarthritis but no history of rheumatoid arthritis, recent infections requiring antibiotics, prior knee surgeries, or injections within the last 6 weeks. Pregnant individuals or those with diabetes, transplant history, decision-making impairments, recent cancer (except basal cell), or severe osteoarthritis are excluded.

What is being tested?

The study tests if injecting Bone Marrow Aspirate Concentrate (BMAC) after meniscectomy can slow down osteoarthritis progression compared to a saline injection. It's randomized and double-blind meaning neither patients nor doctors know who gets BMAC or saline. Outcomes will be measured through patient scores on knee function (IKDC), physical exams, MRIs, X-rays and joint fluid analysis.

What are the potential side effects?

Potential side effects may include pain at the bone marrow aspiration site; risk of infection; swelling; bruising; allergic reactions to materials used during procedure; discomfort from the injection itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Select...

I need surgery for a painful knee tear.

Select...

My knee issue was confirmed by MRI and a special camera exam.

Select...

My knee arthritis is mild to moderate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have rheumatoid arthritis or another autoimmune disorder.

Select...

I am having or have had surgery for ligament or cartilage repair.

Select...

I currently have an infection.

Select...

I am unable to make my own medical decisions.

Select...

I have had surgery on the meniscus in my knee before.

Select...

I have had an organ or bone marrow transplant.

Select...

My knee arthritis is severe on X-rays.

Select...

I have a history of diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

International Knee Documentation Committee (IKDC) Score

Secondary study objectives

Patient reported outcomes throughout follow-up period

Patient reported outcomes throughout follow-up period (IKDC)

Patient reported outcomes throughout follow-up period (KOOS)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)Experimental Treatment2 Interventions

Subjects will undergo the scheduled meniscectomy procedure. Following the procedure the investigator will make a small incision and create the marrow access channel in the proximal tibia. The experimental group will then have bone marrow harvested and BMAC will be prepared using a BMAC harvesting system. The automated centrifuge system rapidly concentrates cellular contents and growth factors in bone marrow aspirate using flow cytometry. The BMAC will be injected intra-articularly.

Group II: Meniscectomy with PlaceboPlacebo Group1 Intervention

Subjects will undergo the same meniscectomy procedure and will also have an incision and marrow access channel made in the proximal tibia, however no bone marrow will be harvested. The control group will have a placebo injection of saline into the affected knee.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspirate Concentrate

2016

Completed Phase 4

~200

Standard Meniscectomy

2017

Completed Phase 4

~90