Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis

April 27, 2021 updated by: Hanan Jafar

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Recruiting
        • Cell Therapy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

42 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanan Jafar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2017

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlloKneeUJCTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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