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Adipose-Derived Stem Cell Injections for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03467919
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University

Brief Summary:
This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of autologous Adipose-Derived Stem Cells (ADSC) combined with platelet-rich plasma (PRP) versus conventional therapy of Intra-articular injection of corticosteroid.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Knee Pain Procedure: Stem Cell injection Drug: Corticosteroid injection Phase 3

Detailed Description:

This study will be a randomized controlled trial to compare outcomes between intra-articular injection of ADSC+PRP and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the knee. ADSC will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation (Adiprep) in the clinic room.

PRP is prepped from the peripheral blood. Up to 30 ml of peripheral blood is drawn from the peripheral blood vessel then it is transferred to the tube for centrifugation to yield a platelet-rich plasma layer. This process is expected to take up to 1 hour.

To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3).

In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Adipose-Derived Stem Cell With Platelet-Rich Plasma Injections on Knee Osteoarthritis
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stem Cells (with PRP)
Intra-articular knee injection of autologous Adipose-Derived Mesenchymal Stem Cells (ADSC) harvested from the thigh using tumescent liposuction and processing with syringe emulsification and cell concentration using Harvest Adiprep System. This harvested tissue will then be combined with leukocyte poor-platelet-rich plasma (PRP) processed using the Harvest PRP system and then injected into the patient's knee.
Procedure: Stem Cell injection
Harvesting of adipose-derived stem cells and platelet-rich plasma with intra-articular injection
Active Comparator: Conventional therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg)
Drug: Corticosteroid injection
Sham harvesting of adipose tissue and peripheral blood without intra-articular injection. Intra-articular injection of corticosteroid



Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score [ Time Frame: 24 months ]
    Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms


Secondary Outcome Measures :
  1. Lysholm score [ Time Frame: 24 months ]
    Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)

  2. Veterans RAND 12 (VR-12) score [ Time Frame: 24 months ]
    Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy


Other Outcome Measures:
  1. MRI Cartilage Scan [ Time Frame: 24 months ]
    Cartilage thickness on MRI using T2-weighted cartilage mapping



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 35 and 75 years-old
  • Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3.
  • Working understanding of the English language and able to fully understand the procedure
  • Capable of providing informed consent
  • Able to complete online, in-person or phone surveys for the purposes of follow-up
  • Capable of understanding pre- and post-procedure care instructions
  • Ambulatory at baseline
  • Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.

Exclusion Criteria:

  • Age < 35 or > 75 years old
  • Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )
  • Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)
  • Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
  • Co-morbidity with rheumatologic condition, inflammatory arthritis
  • Currently undergoing immunomodulatory therapy
  • Uncontrolled endocrine disorder
  • BMI >35
  • Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C >7.0)
  • Pregnancy or planned pregnancy
  • previous stem cell injection into treatment joint
  • Patient scheduled to undergo any concomitant surgical procedures.
  • Coagulopathy or anticoagulant treatment
  • Chronic pain involving multiple body parts or opioid medication management

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467919


Contacts
Contact: Michelle Backer, BS (650) 721-7653 mbacker@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Jason L Dragoo, MD       mbacker@stanford.edu   
Principal Investigator: Jason L Dragoo, MD         
Principal Investigator: Eugene Y Roh, MD         
Sub-Investigator: Adrian DK Le, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jason L Dragoo, MD Stanford University
Principal Investigator: Eugene Y Roh, MD Stanford University
Study Director: Adrian DK Le, MD Stanford University

Responsible Party: Jason L. Dragoo, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03467919     History of Changes
Other Study ID Numbers: 41688
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jason L. Dragoo, Stanford University:
osteoarthritis
stem cell
knee pain
adipose derived stem cell
injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases