Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis

Knee Osteoarthrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02963727
• Other study ID #: AlloKneeUJCTC
• Status: Recruiting
• Phase: Phase 1
• Start date: January 27, 2017
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: University of Jordan
• Contact: Hanan Jafar, PhD
• Phone: 00962798871087
• Email: hanan.jafar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthrosis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Wharton Jelly derived mesenchymal stem cell
Intra-articular Wharton Jelly derived mesenchymal stem cell injection.

Locations

Country	Name	City	State
Jordan	Cell Therapy Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Hanan Jafar

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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).	12 months