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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year, 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am over 18 years old.

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I need surgery for a painful knee tear.

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

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My knee arthritis is mild to moderate.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

International Knee Documentation Committee (IKDC) Score

Secondary outcome measures

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,431 Total Patients Enrolled

25 Trials studying Osteoarthritis

3,138 Patients Enrolled for Osteoarthritis

Brian J Cole, MD, MBAPrincipal InvestigatorMidwest Orthopaedics at Rush

Media Library

Bone Marrow Aspirate Concentrate Clinical Trial Eligibility Overview. Trial Name: NCT02582489 — N/A

Osteoarthritis Research Study Groups: Meniscectomy with Placebo, Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)

Osteoarthritis Clinical Trial 2023: Bone Marrow Aspirate Concentrate Highlights & Side Effects. Trial Name: NCT02582489 — N/A

Bone Marrow Aspirate Concentrate 2023 Treatment Timeline for Medical Study. Trial Name: NCT02582489 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate participation of individuals enrolled in this research?

"Affirmative, clinicaltrials.gov confirms that this research endeavor is actively searching for volunteers. Initially posted on December 22nd 2017 and last updated January 3rd 2022, the trial necessitates 100 individuals at one site of recruitment."

Answered by AI

Are there any unfilled vacancies for participants in this clinical trial?

"The data from clinicaltrials.gov demonstrates that this experiment is searching for patients at the present time, having been initially posted on December 22nd 2017 and updated most recently on January 3rd 2022."

Answered by AI