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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

BMAC Trial 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.Check my eligibility
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.See study design
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.

BMAC Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patients with at least one severe adverse event
Secondary outcome measures
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 outcome measures
Rheumatic disease characterization

BMAC 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
1,120 Previous Clinical Trials
1,521,397 Total Patients Enrolled
5 Trials studying Osteoarthritis
327 Patients Enrolled for Osteoarthritis

Media Library

Bone Marrow Aspirate Concentrate (BMAC) (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04716803 — N/A
Osteoarthritis Research Study Groups: Bone marrow aspiration concentrate using the Angel System
Osteoarthritis Clinical Trial 2023: Bone Marrow Aspirate Concentrate (BMAC) Highlights & Side Effects. Trial Name: NCT04716803 — N/A
Bone Marrow Aspirate Concentrate (BMAC) (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04716803 — N/A

Frequently Asked Questions

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

Is this research protocol open to participants aged 80 or younger?

"As specified in the enrollment prerequisites, this clinical trial can only accept individuals between 45 to 75 years of age."

Answered by AI

Are there any vacancies available to participate in this experiment?

"According to the clinicaltrials.gov website, this research study is still accepting participants. The trial first appeared on July 8th 2020 and was recently revised in January 24th 2022."

Answered by AI

Is it possible for me to take part in this experiment?

"This clinical trial seeks 10 individuals between 45 and 75 who suffer from osteoarthritis of the knee. To be eligible, these patients must exhibit persistent pain that has not responded to conventional therapy such as acetametaphine, NSAIDs, physical modalities, or intraarticular injections for joint lubrication; have Kellgren Lawrence radiographic grade IV; require total knee arthroscopy by primary care provider/orthopedist; and are male or female aged 45-75."

Answered by AI

How many participants are currently enrolled in this clinical trial?

"Affirmative, clinicaltrials.gov states that this trial is currently enrolling patients. It was first put online on July 8th 2020 and last updated January 24th 2022, with a requirement of 10 participants at 1 medical facility."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
California
How old are they?
18 - 65
What site did they apply to?
University of California San Diego Koman Outpatient Pavilion
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
Recent research and studies
clinicaltrials.govStudy
Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
Kenneth Kalunian 2020. "Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04716803.
All > Knee Osteoarthritis
~2 spots leftby Apr 2025
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