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Stem Cell Therapy
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)
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
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,731 Total Patients Enrolled
6 Trials studying Osteoarthritis
3,327 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been recommended to undergo knee surgery by your doctor.You have knee pain that has not improved with common treatments like painkillers, physical therapy, or injections.
Research Study Groups:
This trial has the following groups:- Group 1: Bone marrow aspiration concentrate using the Angel System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.