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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
Must not have
Age < 35 or > 70 years old
Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 24 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am between 35 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am younger than 35 or older than 70.
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My X-rays show I have no, mild, or severe arthritis.
Select...
I have had an injury or surgery on the fat pad below my kneecap.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
Secondary study objectives
Lysholm score
Tegner score
VR-12
Other study objectives
Magnetic Resonance Imaging

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,803 Previous Clinical Trials
2,822,094 Total Patients Enrolled
12 Trials studying Osteoarthritis
817 Patients Enrolled for Osteoarthritis
Stanford UniversityOTHER
2,469 Previous Clinical Trials
17,501,718 Total Patients Enrolled
17 Trials studying Osteoarthritis
5,151 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
~3 spots leftby Dec 2025
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