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Intra-articular Injection of MSCs in Treatment of Knee OA

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ClinicalTrials.gov Identifier: NCT03028428
Recruitment Status : Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
YU TANG, Affiliated Hospital of Jiangsu University

Tracking Information
First Submitted Date  ICMJE January 20, 2017
First Posted Date  ICMJE January 23, 2017
Last Update Posted Date January 30, 2018
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
adverse events [ Time Frame: 1 Year ]
Number of participants with adverse events as measure of safety and tolerability
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
WOMAC assessment [ Time Frame: 3 months 6 months and 12 months ]
Number of participants with a change in joint function from baseline WOMAC assessment
Change History Complete list of historical versions of study NCT03028428 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
  • radiographic evidence [ Time Frame: 1 Year ]
    Number of participants with a change in cartilage thickness of knee OA using MRI
  • WOMAC assessment [ Time Frame: 1 Year ]
    Number of participants with a change in joint function from baseline WOMAC assessment
  • VAS [ Time Frame: 1 Year ]
    Number of participants with a change in arthritis pain scores on the visual analogue scale
  • SF-36 [ Time Frame: 1 Year ]
    Number of participants with a change in SF-36
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • radiogrpahic evidence [ Time Frame: 3 months 6 months and 12 months ]
    Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellgren Lawrence grading system
  • adverse events [ Time Frame: 3 months 6 months and 12 months ]
    Number of participants with adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-articular Injection of MSCs in Treatment of Knee OA
Official Title  ICMJE Clinical Research on Intra-articular Injection of Human Autologous MSCs in Treatment of Knee OA
Brief Summary In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
Detailed Description

Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Currently, there are few effective treatments available for patients suffering from OA.

Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means they have the ability to make copies of themselves and to turn into other kinds of cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of osteoarthritis, but much of the research is still in the early stages. In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A Randomized, Double Blind, Phase-II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients with Osteoarthritis of Knee
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Stem Cells
  • MSC
Intervention  ICMJE
  • Biological: Placenta Derived Mesenchymal Stem Cell
    1ml 1*10^7 Placenta Derived Mesenchymal Stem Cell administered into the knee joint once
    Other Name: Mesenchymal Stromal Cells (MSCs)
  • Drug: Sodium Hyaluronate
    Sodium hyaluronate administered into the knee joint once
    Other Name: hyaluronate
Study Arms  ICMJE
  • Experimental: Placenta Derived Mesenchymal Stem Cell
    Placenta Derived Mesenchymal Stem Cell administered into the knee joint once
    Intervention: Biological: Placenta Derived Mesenchymal Stem Cell
  • Active Comparator: sodium hyaluronate
    Sodium hyaluronate administered into the knee joint once
    Intervention: Drug: Sodium Hyaluronate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2017)
1
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients between 40-75 years of age with symptomatic moderate to severe (Kellgren-Lawrence III or IV) primary osteoarthritis of the knee
  2. Idiopathic or secondary osteoarthritis of the knee with grade 2,3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
  3. No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
  4. No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
  5. Adequate bone marrow, liver, and renal functions
  6. Body weight >40 kg
  7. Body Mass Index <40
  8. Negative for (HIV, HTLV1&2, Hep A, B, C, syphilis) infection as determined by approved serological testing
  9. Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection.
  10. Ability to provide written informed consent.

Exclusion Criteria:

  1. Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
  2. Patients with varus or valgus malalignment >5 degrees as measured by 4 foot standing antero-posterior radiographs
  3. Patients with a history of a previous subtotal medial or lateral meniscectomy
  4. Patients with a history of septic arthritis in the affected joint
  5. Patients with a history of a prior intra-articular knee fracture
  6. Severe bleeding diathesis
  7. Contraindication to bone marrow aspiration and/or biopsy
  8. Active infection
  9. Bone marrow failure
  10. Cytopenia
  11. Patients who have previously received radiotherapy to the pelvis
  12. Patients who have been on chemotherapy from within a year of the date of informed
  13. Patients with positive serological test for (HIV, HTLV1&2, Hep A, B, C, syphilis)
  14. Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)
  15. Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g. patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03028428
Other Study ID Numbers  ICMJE AHJiangsuU-FSK-MSC-OA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party YU TANG, Affiliated Hospital of Jiangsu University
Study Sponsor  ICMJE Affiliated Hospital of Jiangsu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: YU TANG, Dr. Affiliated Hospital of Jiangsu University
PRS Account Affiliated Hospital of Jiangsu University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP