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 : April 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Knee Osteoarthrosis | Biological: Wharton Jelly derived mesenchymal stem cell | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
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 2021 |
Estimated Study Completion Date : | December 2021 |

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
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Biological: Wharton Jelly derived mesenchymal stem cell
Intra-articular Wharton Jelly derived mesenchymal stem cell injection. |
- 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
- 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 |
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:
- Sublaxation beyond 20 degrees of the bones of the knee joint
- Oral anticoagulants or heparin therapy
- Heart failure or arrhythmia
- Body Mass Index > 35
- Uncontrolled Diabetes Mellitus.
- Evidence of Infectious Diseases.
- Active infection
- Malignancy
- Pregnancy
- Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.
- Unreliable patients
- Non-resident in Jordan

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
Contact: Hanan Jafar, PhD | 00962798871087 | hanan.jafar@gmail.com |
Jordan | |
Cell Therapy Center | Recruiting |
Amman, Jordan, 11942 | |
Contact: Abdalla Awidi, MD 0096265355000 ext 23960 abdalla.awidi@gmail.com |
Study Director: | Abdallah Awidi, MD | Cell Therapy Center |
Responsible Party: | Hanan Jafar, Researcher, University of Jordan |
ClinicalTrials.gov Identifier: | NCT02963727 |
Other Study ID Numbers: |
AlloKneeUJCTC |
First Posted: | November 15, 2016 Key Record Dates |
Last Update Posted: | April 28, 2021 |
Last Verified: | April 2021 |
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 |
osteoarthrosis Knee Wharton Jelly |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |