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Stem Cell Therapy

Microfracture vs ADSC for Knee Cartilage Repair

N/A
Recruiting
Led By Jason Dragoo, 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
Must be between ages 18 and 50 years
Must have a discrete, contained chondral defect less than 400mm^2 located on the medial or lateral femoral condyle
Must not have
Pre-existing osteoarthritis (Kellegren-Lawrence Grade ≥2)
Ages younger than 18 years and older than 50 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, 6 months, 12 months, and 24 months post-operatively.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two different methods for repairing damage to cartilage in the knee. The first, microfracture, is commonly used. The second, which uses stem cells from fat tissue, is being tested to see if it results in better repair.

Who is the study for?
This trial is for individuals aged 18-50 with a specific knee cartilage defect less than 400mm^2 on the femoral condyle and neutral leg alignment. It's not for those over 50 or under 18, with a BMI over 30, advanced osteoarthritis, or previous knee cartilage procedures.
What is being tested?
The study compares two treatments for knee cartilage defects: microfracture (standard care) and application of adipose-derived stem cells (ADSCs) on a collagen scaffold to potentially improve regeneration at the injury site.
What are the potential side effects?
Possible side effects may include pain at the treatment site, swelling, infection risk from procedures, and potential differences in how well each method repairs the cartilage which could affect joint function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old.
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I have a specific knee cartilage damage smaller than 400mm^2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have moderate to severe arthritis.
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I am under 18 or over 50 years old.
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I have had surgery on my cartilage before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, 6 months, 12 months, and 24 months post-operatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, 6 months, 12 months, and 24 months post-operatively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Health Scores on the KOOS Questionnaire
Secondary study objectives
Activity Level on the Tegner Activity Scale
Cartilage Composition Assessment by MRI Scan
Functionality Scores on the Lysholm Scale
+2 more

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: ADSC ApplicationExperimental Treatment1 Intervention
Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy.
Group II: Microfracture ArmActive Control1 Intervention
Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,491 Previous Clinical Trials
17,518,147 Total Patients Enrolled
18 Trials studying Osteoarthritis
5,147 Patients Enrolled for Osteoarthritis
University of KentuckyOTHER
194 Previous Clinical Trials
223,708 Total Patients Enrolled
1 Trials studying Osteoarthritis
66 Patients Enrolled for Osteoarthritis
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,963 Total Patients Enrolled
13 Trials studying Osteoarthritis
846 Patients Enrolled for Osteoarthritis
Jason Dragoo, MDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
3 Previous Clinical Trials
198 Total Patients Enrolled
2 Trials studying Osteoarthritis
174 Patients Enrolled for Osteoarthritis
Seth L Sherman, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
59 Total Patients Enrolled
1 Trials studying Osteoarthritis
29 Patients Enrolled for Osteoarthritis

Media Library

ADSC Application (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02090140 — N/A
Osteoarthritis Research Study Groups: ADSC Application, Microfracture Arm
Osteoarthritis Clinical Trial 2023: ADSC Application Highlights & Side Effects. Trial Name: NCT02090140 — N/A
ADSC Application (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02090140 — N/A
Osteoarthritis Patient Testimony for trial: Trial Name: NCT02090140 — N/A
~2 spots leftby Dec 2025
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