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Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis

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ClinicalTrials.gov Identifier: NCT02963727
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hanan Jafar, University of Jordan

Brief Summary:
Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed with Knee osteoarthrosis

Condition or disease Intervention/treatment Phase
Knee Osteoarthrosis Biological: Wharton Jelly derived mesenchymal stem cell Phase 1

Detailed Description:
Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to strict inclusion and exclusion criteria. These patients will be injected with Wharton Jelly derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Wharton Jelly Derived Mesenchymal Stem Cells (WJMSC) for Advanced Stage III and IV KOA
Actual Study Start Date : January 27, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Wharton Jelly mesenchymal stem cell
Intra-articular Wharton Jelly derived mesenchymal stem cell injection will be given for each patient in 2 doses, 50 million of WJMSC in each dose
Biological: Wharton Jelly derived mesenchymal stem cell
Intra-articular Wharton Jelly derived mesenchymal stem cell injection.




Primary Outcome Measures :
  1. Evaluation of the safety and tolerability of the intra articular injection [ Time Frame: 6 months ]
    patients will be monitored for any adverse events resulting from the intraarticular injection of WJMSC


Secondary Outcome Measures :
  1. Assessment of the efficacy of intra-articular injection of WJMSC [ Time Frame: 12 months ]
    The efficacy of the intra-articular injection of WJMSC will be assessed by Magnetic Resonance Imaging (MRI).



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Ages Eligible for Study:   42 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe KOA stage III or IV by Laurance & Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.
  • Willing to participate by signing the informed consent

Exclusion Criteria:

  1. Sublaxation beyond 20 degrees of the bones of the knee joint
  2. Oral anticoagulants or heparin therapy
  3. Heart failure or arrhythmia
  4. Body Mass Index > 35
  5. Uncontrolled Diabetes Mellitus.
  6. Evidence of Infectious Diseases.
  7. Active infection
  8. Malignancy
  9. Pregnancy
  10. Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.
  11. Unreliable patients
  12. Non-resident in Jordan

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): NCT02963727


Contacts
Contact: Hanan Jafar, PhD 00962798871087 hanan.jafar@gmail.com

Locations
Jordan
Cell Therapy Center Recruiting
Amman, Jordan, 11942
Contact: Abdalla Awidi, MD    0096265355000 ext 23960    abdalla.awidi@gmail.com   
Sponsors and Collaborators
Hanan Jafar
Investigators
Study Director: Abdallah Awidi, MD Cell Therapy Center

Responsible Party: Hanan Jafar, Researcher, University of Jordan
ClinicalTrials.gov Identifier: NCT02963727     History of Changes
Other Study ID Numbers: AlloKneeUJCTC
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hanan Jafar, University of Jordan:
osteoarthrosis
Knee
Wharton Jelly

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