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Trial record 27 of 101 for:    stem cell arthritis AND Mesenchymal

Intra-articular Injection of MSCs in Treatment of Knee OA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Stem Cells MSC Biological: Placenta Derived Mesenchymal Stem Cell Drug: Sodium Hyaluronate Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
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
Official Title: Clinical Research on Intra-articular Injection of Human Autologous MSCs in Treatment of Knee OA
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Placenta Derived Mesenchymal Stem Cell
Placenta Derived Mesenchymal Stem Cell administered into the knee joint once
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)

Active Comparator: sodium hyaluronate
Sodium hyaluronate administered into the knee joint once
Drug: Sodium Hyaluronate
Sodium hyaluronate administered into the knee joint once
Other Name: hyaluronate




Primary Outcome Measures :
  1. adverse events [ Time Frame: 1 Year ]
    Number of participants with adverse events as measure of safety and tolerability


Secondary Outcome Measures :
  1. radiographic evidence [ Time Frame: 1 Year ]
    Number of participants with a change in cartilage thickness of knee OA using MRI

  2. WOMAC assessment [ Time Frame: 1 Year ]
    Number of participants with a change in joint function from baseline WOMAC assessment

  3. VAS [ Time Frame: 1 Year ]
    Number of participants with a change in arthritis pain scores on the visual analogue scale

  4. SF-36 [ Time Frame: 1 Year ]
    Number of participants with a change in SF-36



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03028428


Sponsors and Collaborators
Affiliated Hospital of Jiangsu University
Investigators
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Principal Investigator: YU TANG, Dr. Affiliated Hospital of Jiangsu University

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Responsible Party: YU TANG, Dr., Affiliated Hospital of Jiangsu University
ClinicalTrials.gov Identifier: NCT03028428     History of Changes
Other Study ID Numbers: AHJiangsuU-FSK-MSC-OA
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Keywords provided by YU TANG, Affiliated Hospital of Jiangsu University:
Osteoarthritis
Stem Cell
Knee
Mesenchymal Stem Cell
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents