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

• Sponsor: Liaocheng People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03166865
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs); Other: Hyaluronic acid	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
• Anticipated Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)	Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs); Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma
Other: Control group Intraarticular injection of hyaluronic acid	Other: Hyaluronic acid; intra-articular injection of Hyaluronic Acid

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in visual analogue scale (VAS) [Baseline, 1, 3, 6 and 12 weeks]

   Visual analogue scale (VAS)

2. Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score [Baseline, 1, 3, 6 and 12 weeks]

   WOMAC

3. Change From Baseline in knee society score (KSS) [Baseline, 1, 3, 6 and 12 weeks]

   knee society score (KSS)

4. Change From Baseline in MOS item short from health survey(SF-36) [Baseline, 1, 3, 6 and 12 weeks]

   The MOS item short from health survey(SF-36)

Secondary Outcome Measures

1. The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI [Baseline, 1, 3, 6 and 12 weeks]

2. The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid [Baseline, 1, 3, 6 and 12 weeks]

   The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liaocheng city people's hospital	Liaocheng	Shandong	China	0635

Sponsors and Collaborators

• Liaocheng People's Hospital

Investigators

• Study Director: Dawang Wang, Ph.D., Liaocheng People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liaocheng People's Hospital
• ClinicalTrials.gov Identifier: NCT03166865
• Other Study ID Numbers: lcsrmyygk
• First Posted: May 25, 2017
• Last Update Posted: Jun 4, 2018
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Liaocheng People's Hospital: osteoarthritis (OA); mesenchymal stem cells(MSC)
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hyaluronic Acid

Study Results

No Results Posted as of Jun 4, 2018