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Stem Cell Transplantation + Arthroscopy for Knee Osteoarthritis

N/A
Recruiting
Led By Seth L Sherman, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 35 and 70 years-old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 24 months
Awards & highlights

Study Summary

This trial is comparing two different treatments for patients with mild to moderate osteoarthritis. One treatment involves harvesting fat from the patient and transplanting stem cells from that fat, in addition to standard arthroscopic procedures. The other treatment is just the standard arthroscopic procedures without the stem cell transplant.

Who is the study for?
This trial is for adults aged 35-70 with mild to moderate knee osteoarthritis who haven't had relief from physical therapy and anti-inflammatory meds. It's not for those outside the age range, with severe or little to no arthritis, prior fat pad injuries/surgeries, or recent knee surgeries.Check my eligibility
What is being tested?
The study compares two treatments: one group receives standard arthroscopic treatment plus stem cells from their own fat tissue; the other gets just the standard treatment without stem cells. The goal is to see which method better improves knee function.See study design
What are the potential side effects?
Potential side effects may include pain at the injection site, swelling, infection risk increase due to surgery and stem cell transplantation, as well as typical risks associated with arthroscopic procedures like bleeding or blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 35 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 24 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
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
Secondary outcome measures
Lysholm score
Tegner score
VR-12
Other outcome measures
Magnetic Resonance Imaging

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stem CellsExperimental Treatment1 Intervention
Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.
Group II: PlaceboActive Control1 Intervention
Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,854 Total Patients Enrolled
12 Trials studying Osteoarthritis
808 Patients Enrolled for Osteoarthritis
Stanford UniversityOTHER
2,393 Previous Clinical Trials
17,341,207 Total Patients Enrolled
16 Trials studying Osteoarthritis
5,026 Patients Enrolled for Osteoarthritis
Seth L Sherman, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
47 Total Patients Enrolled

Media Library

Osteoarthritis Clinical Trial 2023: Arthroscopic debridement only Highlights & Side Effects. Trial Name: NCT03014401 — N/A

Frequently Asked Questions

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

Are researchers still accepting new participants for this study?

"Data on clinicaltrials.gov reflects that this trial is actively searching for participants; it was initially published on May 1st 2016 and last modified upon June 2nd 2021."

Answered by AI

To which population is this research opportunity accessible?

"To be eligible to join this trial, applicants must have arthrosis and age between 35 and 70. As of now, a total of 29 individuals have been accepted into the study."

Answered by AI

Is the participant threshold for this research project restricted to persons below seventy years of age?

"According to the eligibility criteria, only individuals between 35 and 70 years old are qualified for this trial. Conversely, there exist 38 trials that cater towards minors, as well as 657 studies designed for seniors."

Answered by AI

How many individuals are included in this research project?

"Affirmative. Data published on clinicaltrials.gov demonstrates that this medical study is actively seeking enrollees, having been first posted in May 2016 and recently updated in June 2021. The research team is looking to recruit 29 volunteers from two locations."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Maryland
California
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Stanford University
Kerlan Jobe Orthopedic Institute
UC Health Steadman Hawkins Clinic - Denver Inverness
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

pain relief money for study. I'd like to find something that works to help with the pain with the hope that I can avoid taking pain medications. Currently I just deal with the pain and take natural supplements.
PatientReceived 2+ prior treatments
~5 spots leftby Dec 2025