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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have an adjusted Western Ontario and McMaster Universities Arthritis Index (WOMAC) (100-point scale) of > 25 and <90
Males and females 18 - 45 with a preceding history (>1 and < 20 years ago) of significant knee trauma or trauma- related knee surgery
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upyear 1
Awards & highlights
No Placebo-Only Group
SVF Trial Summary
This trial is testing a single injection of a person's own fat cells to treat knee osteoarthritis after an injury.
SVF Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSVF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events
Other outcome measures
General Health scores - Patient-Reported Outcomes Measurement Information System (PROMIS 29)
Knee Pain scores - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Knee Pain scores - Visual Analog Scale (VAS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
SVF Trial Design
1Treatment groups
Experimental Treatment
Group I: a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF)Experimental Treatment1 Intervention
a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA)
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,208 Previous Clinical Trials
1,030,127 Total Patients Enrolled
7 Trials studying Osteoarthritis
674 Patients Enrolled for Osteoarthritis
Claude T Moorman, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Subjects must present with symptomatic (injured knee) VAS pain > 4You had a major knee injury or surgery between 1 and 20 years ago, and you're between 18 and 45 years old.Subjects must be able to return for multiple follow-up visits, including a procedure visit.You have a post-traumatic osteoarthritis (PTOA) of the knee.You have arthritis symptoms that score between 25 and 90 on the WOMAC scale.You have been experiencing knee pain for at least 3 months and have tried at least two different treatments like painkillers, physical therapy, injections, or weight loss, but still have pain.You must be willing to voluntarily give written Informed Consent to participate in the study and sign the HIPAA authorization before any study procedures are performed.You have been experiencing knee pain for at least 3 months and have tried at least two different treatments, such as pain medication, physical therapy, knee injections, or weight loss, but the pain has not improved.
Research Study Groups:
This trial has the following groups:- Group 1: a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF)
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: NCT05515523 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are minors allowed to participate in this experiment?
"Patients aged 18 to 45 are eligible for this clinical trial, whereas there are 30 other trials open for minors and 583 for seniors."
Answered by AI
Are there still vacancies for individuals in this clinical trial?
"According to the clinicaltrials.gov, this particular trial has not been actively recruiting patients since October 31st 2022 and is currently inactive. Despite this, 613 other studies are presently enrolling individuals for their respective research initiatives."
Answered by AI
Who would be eligible to join this research endeavor?
"In order to be considered for the trials, potential participants must possess arthrosis and fall between 18-45 years old. A total of 10 patients will eventually join this research project."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
Louisiana
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
2
3+
What site did they apply to?
Wake Forest University Health Sciences
Why did patients apply to this trial?
do not want knee replacement if possible. Pain in knees from a motorcycle accident when I was in my 20’s.
PatientReceived 1 prior treatment
I have tried to get adequate pain relief with several otc and rx for osteo arthritis but I haven't had any good results due to my being on Eliquis for DVT.
PatientReceived no prior treatments
I have had more than a year of Physical Therapy, Alternate Steroid and Synvisc Injections Meloxicam and all OTC meds. My Pain at on movement is 10, For Bilateral Knee Triple Compartmental Osteoarthritis, I know have worsening Spinal Arthritis as well. I entered another trial for that. I was checking for Spinal Arthritis trials and found this one. As its not covered by Insurance I cant afford to have my NP organize it with a Dr in her Practice who offers it.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long does screening take? How long does the trial go for.?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
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