Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

Official title:

Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03166865
• Other study ID #: lcsrmyygk
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: June 2018
• Source: Liaocheng People's Hospital
• Contact: Changhui Zhou, Ph.D.
• Phone: 86-0635-8272202
• Email: zhouchanghui008[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• 30-70 years old.

• No serious infection, chronic diseases, diabetes and tuberculosis.

• Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification.

• Written informed consents were obtained from all subjects.

Exclusion Criteria:

• Pregnant women or cognitively impaired adults.

• Inflammatory or post infectious arthritis.

• Intra-articular drug injection within the previous 2 months.

• Serious medical illness with a life expectancy of less than 1 year.

• Prior admission for substance abuse.

• Arthroscopy during the previous 6 months.

• Systemic autoimmune rheumatic disease.

• Poorly controlled diabetes mellitus.

• Immunosuppressive or anticoagulant treatments.

• Treatment with corticosteroids in the 3 months prior to inclusion in the study.

• NSAID therapy within 15 days prior to inclusion in the study.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Biological:
• Umbilical-cord mesenchymal stromal cells (UC-MSCs)
Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma

Other:
• Hyaluronic acid
intra-articular injection of Hyaluronic Acid

Locations

Country	Name	City	State
China	Liaocheng city people's hospital	Liaocheng	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Liaocheng People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in visual analogue scale (VAS)	Visual analogue scale (VAS)	Baseline, 1, 3, 6 and 12 weeks
Primary	Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score	WOMAC	Baseline, 1, 3, 6 and 12 weeks
Primary	Change From Baseline in knee society score (KSS)	knee society score (KSS)	Baseline, 1, 3, 6 and 12 weeks
Primary	Change From Baseline in MOS item short from health survey(SF-36)	The MOS item short from health survey(SF-36)	Baseline, 1, 3, 6 and 12 weeks
Secondary	The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI		Baseline, 1, 3, 6 and 12 weeks
Secondary	The IL-1ß, IL-6, PGE-2, TGF-ß, TNF-a and IGF-1 of articular cavity fluid	The IL-1ß, IL-6, PGE-2, TGF-ß, TNF-a and IGF-1 of articular cavity fluid	Baseline, 1, 3, 6 and 12 weeks