Back to resultsUse of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis
Primary Purpose
Knee Osteoarthrosis
Status
Unknown status
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
Wharton Jelly derived mesenchymal stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthrosis focused on measuring osteoarthrosis, Knee, Wharton Jelly
Eligibility 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:
- 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
Sites / Locations
- Cell Therapy CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wharton Jelly mesenchymal stem cell
Arm Description
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
Outcomes
Primary Outcome Measures
Evaluation of the safety and tolerability of the intra articular injection
patients will be monitored for any adverse events resulting from the intraarticular injection of WJMSC
Secondary Outcome Measures
Assessment of the efficacy of intra-articular injection of WJMSC
The efficacy of the intra-articular injection of WJMSC will be assessed by Magnetic Resonance Imaging (MRI).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02963727
Brief Title
Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hanan Jafar
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed with Knee osteoarthrosis
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthrosis
Keywords
osteoarthrosis, Knee, Wharton Jelly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wharton Jelly mesenchymal stem cell
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Wharton Jelly derived mesenchymal stem cell
Intervention Description
Intra-articular Wharton Jelly derived mesenchymal stem cell injection.
Primary Outcome Measure Information:
Title
Evaluation of the safety and tolerability of the intra articular injection
Description
patients will be monitored for any adverse events resulting from the intraarticular injection of WJMSC
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment of the efficacy of intra-articular injection of WJMSC
Description
The efficacy of the intra-articular injection of WJMSC will be assessed by Magnetic Resonance Imaging (MRI).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan Jafar, PhD
Phone
00962798871087
Email
hanan.jafar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdallah Awidi, MD
Organizational Affiliation
Cell Therapy Center
Official's Role
Study Director
Facility Information:
Facility Name
Cell Therapy Center
City
Amman
ZIP/Postal Code
11942
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdalla Awidi, MD
Phone
0096265355000
Ext
23960
Email
abdalla.awidi@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis
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