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Adipose-Derived Stem Cells for Knee Osteoarthritis

This study is looking at how well a treatment using Adipose-Derived Stem Cells (stem cells from your own fat) works for knee osteoarthritis. Researchers want to compare this treatment, which involves taking fat cells and putting them into your knee after standard arthroscopic surgery (a type of keyhole surgery for joints), to standard arthroscopic surgery alone. They hope the stem cells might help repair tissue and reduce inflammation. You could be eligible if you are between 35 and 70 years old and are scheduled for certain knee procedures like meniscal debridement or chondroplasty. The main goal is to see if adding stem cells improves your knee function and pain scores (KOOS score) 24 months after surgery. The study is currently unclear on its recruitment status and plans to enroll 29 participants.

Study design
This is an interventional study comparing two treatment groups for knee osteoarthritis. It plans to enroll 29 participants.
What's involved
Participants will undergo either arthroscopic debridement with stem cell transplantation or arthroscopic debridement only. Follow-up will continue for 24 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after surgery to assess their KOOS score.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03014401

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

UNKNOWN
NAAges 35–70InterventionalTreatment
University of Colorado, Denver
~29 participants
Updated 2024-04-25 on ClinicalTrials.gov
What's tested:Arthroscopic debridement with stem cell transplantationArthroscopic debridement only

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
Measured over The study will end after 24 month follow-up is completed in all participants.

Conditions

Knee Osteoarthritis

Explore related trials

Osteoarthritis of knee

NCT03014401

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Kerlan Jobe Orthopedic Institute

    Santa Monica, Californiastudy coordinator listed

    Recruiting

  • UC Health Steadman Hawkins Clinic - Denver Inverness

    Denver, Coloradostudy coordinator listed

    Recruiting

  • Stanford University

    Stanford, Californiano site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jason L Dragoo, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
  • Seth L Sherman, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Kaitlyn Whitney
[email protected]
(720) 872-4836
Email the study team

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Eligibility criteria

Inclusion

Age between 35 and 70 years-old
Patient is scheduled to undergo one or a combination of the following procedures:
Meniscal debridement or partial menisectomy
Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
Removal of loose bodies
Chondroplasty
Synovectomy
Soft tissue releases for flexion or extension contracture.
Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
\< 6 months of knee pain or \< 6 months of a significant exacerbation of existing knee pain
Physical examination findings consistent with the proposed surgical procedure.
Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections

Exclusion

Age \< 35 or \> 70 years old
Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
Patient scheduled to undergo any concomitant surgical procedures with the exception of:
Meniscal debridement or partial menisectomy
Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
Removal of loose bodies
Chondroplasty
Synovectomy
Soft tissue releases for flexion or extension contracture
Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
Previous arthroscopy within 1 year
Subchondral edema

What this trial measures

  • Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgeryThe study will end after 24 month follow-up is completed in all participants.

    Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal