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The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthroscopic debridement with stem cell transplantation
Arthroscopic debridement only
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring stem cell, knee pain, osteoarthritis, arthritis, ADSC, fat stem cell

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Kerlan Jobe Orthopedic InstituteRecruiting
  • Stanford University
  • UC Health Steadman Hawkins Clinic - Denver InvernessRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stem Cells

Placebo

Arm Description

Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.

Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation

Outcomes

Primary Outcome Measures

Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal

Secondary Outcome Measures

Tegner score
Patient reported outcomes measures
Lysholm score
Patient reported outcomes measures
VR-12
Patient reported outcomes measures

Full Information

First Posted
December 20, 2016
Last Updated
May 23, 2023
Sponsor
University of Colorado, Denver
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03014401
Brief Title
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
Official Title
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups: Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy. Standard arthroscopic treatment (above) without cell transplant.
Detailed Description
Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties. Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment. The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
stem cell, knee pain, osteoarthritis, arthritis, ADSC, fat stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stem Cells
Arm Type
Experimental
Arm Description
Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic debridement with stem cell transplantation
Intervention Description
Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic debridement only
Intervention Description
standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
Primary Outcome Measure Information:
Title
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
Description
Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal
Time Frame
The study will end after 24 month follow-up is completed in all participants.
Secondary Outcome Measure Information:
Title
Tegner score
Description
Patient reported outcomes measures
Time Frame
6, 12, 24 months
Title
Lysholm score
Description
Patient reported outcomes measures
Time Frame
6, 12, 24 months
Title
VR-12
Description
Patient reported outcomes measures
Time Frame
6, 12, 24 months
Other Pre-specified Outcome Measures:
Title
MRI scans -
Description
Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p
Time Frame
1, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Butler
Phone
(720)872-0112
Email
dragoo.lab@ucdenver.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitie Whitney
Phone
(720)872-0112
Email
dragoo.lab@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason L Dragoo, MD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seth L Sherman, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerlan Jobe Orthopedic Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Galloway, B.S.
Phone
310-829-2663
Email
jasmine.galloway@cskerlanjobe.org
First Name & Middle Initial & Last Name & Degree
Burt Mandelbaum, M.D.
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UC Health Steadman Hawkins Clinic - Denver Inverness
City
Denver
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Butler
Phone
720-872-0112
Email
dragoo.lab@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Kaitie Whitney
Phone
(720)872-0112
Email
dragoo.lab@ucdenver.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

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