Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis

Phase 1

• Conditions: Knee Osteoarthrosis
• Interventions: Biological: Wharton Jelly derived mesenchymal stem cell

• Registration Number: NCT02963727
• Lead Sponsor: Hanan Jafar

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.

Study Timeline

• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-15
• Study Start: 2017-01-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wharton Jelly mesenchymal stem cell	Wharton Jelly derived 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

Primary Outcome Measures

Name	Time	Method
Evaluation of the safety and tolerability of the intra articular injection	6 months	patients will be monitored for any adverse events resulting from the intraarticular injection of WJMSC

Secondary Outcome Measures

Name	Time	Method
Assessment of the efficacy of intra-articular injection of WJMSC	12 months	The efficacy of the intra-articular injection of WJMSC will be assessed by Magnetic Resonance Imaging (MRI).

Trial Locations

Locations (1)

Cell Therapy Center; 🇯🇴 Amman, Jordan