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Stem Cell Therapy
Bone Marrow Concentrate treatment for Osteoarthritis
N/A
Waitlist Available
Led By Christopher Centeno, MD
Research Sponsored by Regenexx, LLC
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 12 months
Awards & highlights
Study Summary
This trial will study whether the Regenexx-SD treatment for knee osteoarthritis leads to improvements in patients' symptoms, and whether these improvements can be measured in changes to the patients' synovial fluid.
Eligible Conditions
- Osteoarthritis of the Knee
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure.
Secondary outcome measures
Correlation between components of synovial fluid and 12 month LEFS
Correlation between components of synovial fluid and 12 month pain scores
Correlation between components of synovial fluid and 6 month Lower Extremity Function Scale (LEFS).
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Knee Synovial Fluid collection before Regenexx-SDExperimental Treatment1 Intervention
Measure components of knee synovial fluid 2-4 days before the Regenexx-SD treatment.
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Who is running the clinical trial?
Regenexx, LLCLead Sponsor
14 Previous Clinical Trials
50,798 Total Patients Enrolled
4 Trials studying Osteoarthritis
158 Patients Enrolled for Osteoarthritis
Christopher Centeno, MDPrincipal InvestigatorRegenexx, LLC
12 Previous Clinical Trials
50,350 Total Patients Enrolled
3 Trials studying Osteoarthritis
110 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have allergies or cannot tolerate the study medication.You have received any kind of knee injections in the past 3 months before the study.You are currently receiving lavage treatment.You have certain joint diseases or other problems in your lower extremities caused by inflammation or an overactive immune system. Examples include rheumatoid arthritis, lupus, and gout.You have experienced muscle or tendon problems caused by taking certain antibiotics (quinolones) or cholesterol-lowering medications (statins).You have severe inflammation of the nerves in your knee or thigh.You are currently taking strong pain medications called opioids on a long-term basis.You have a record of using illegal drugs within the past six months.You have signs of osteoarthritis in one of your knee joints during a physical examination.You are currently taking medicine that prevents blood clotting or weakens your immune system.You have pain, swelling, and difficulty moving your knee due to arthritis.You have arthritis in one or both of your joints and you are between the ages of 35 and 85.
Research Study Groups:
This trial has the following groups:- Group 1: Knee Synovial Fluid collection before Regenexx-SD
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.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03898388 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining for participants in this experiment?
"According to public records hosted on clinicaltrials.gov, this medical trial is not actively looking for participants. Though initially posted in March of 2019, the latest update was made in January 2022 and recruitment has been halted at present. Nonetheless, 693 alternative studies are currently searching for volunteers."
Answered by AI
Does this clinical experiment accept volunteers of advanced age?
"Based on the requirements for participation, those wishing to join must be between 35 and 85 years old."
Answered by AI
For whom is this research endeavor available?
"Those who wish to be included in this arthrosis trial must meet the age criteria of 35-85. Space is limited, and only 600 applicants are being accepted."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Nevada
How old are they?
65+
What site did they apply to?
Interventional Orthopedics of Atlanta
Regenexx Las Vegas
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have pain in my left knee secondary to a radial tear of the meniscus leading to osteoarthritis. I have tried NSAID’s, cortisone without relief.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Is the bone marrow aspirate taken from the hip?
PatientReceived no prior treatments
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