BMAC for Osteoarthritis (BMAC Trial)

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study (12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether a bone marrow concentrate, which is a rich source of stem cells, can improve or preserve the structure of joints in patients with moderate to severe osteoarthritis of the knee.

Who is the study for?

This trial is for men and women aged 45-75 with moderate to severe knee osteoarthritis, who have persistent pain despite standard treatments like acetaminophen, NSAIDs, physical therapy, or injections. They should need a total knee arthroscopy as determined by their primary care provider or orthopedist.

What is being tested?

The study is testing the safety and effectiveness of Bone Marrow Aspirate Concentrate (BMAC) using the Angel System to treat knee osteoarthritis. BMAC contains stem cells that may help preserve or improve joint structure.

What are the potential side effects?

Potential side effects are not specified in the provided information but could include discomfort at the aspiration site, infection risk from injections, and typical surgical risks if applicable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study (12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study (12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (12 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patients with at least one severe adverse event

Secondary study objectives

Self reported health from baseline through end of study measured by the 36-Item Short Form Survey Instrument (SF-36) Health Survey and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Structural change in knee from baseline measured by the VAS (Visual Analog Scale) in the American College of Rheumatology/Knee Osteoarthritis Assessment Scale (ACR/KOAS).

Other study objectives

Rheumatic disease characterization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bone marrow aspiration concentrate using the Angel SystemExperimental Treatment2 Interventions

Bone marrow aspirate concentrate (BMAC) will be administered via injection to the knee of interest on day 14 of the study. Bone marrow aspiration will be concentrated using the Angel System.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspirate Concentrate

2016

Completed Phase 4

~200

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