The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid

Knee Osteoarthritis Clinical Trial

Official title:

The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03357575
• Other study ID #: PUPH20170912
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: November 29, 2017
• Start date: January 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: Ziyi Yang, MD
• Phone: 18810335110
• Email: bjmuyangziyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).

Description:

This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• K / L score of 2-3;

• chronic knee pain;

• no local or systemic infection;

• without obvious contraindication of the joint puncture from hematology and biochemical tests;

• informed consent.

Exclusion Criteria:

• older than 75 years old or less than 18 years old, or without full capacity for civil conduct;

• HIV, hepatitis virus or syphilis virus infection or their serology is positive;

• BMI index is greater than 30;

• congenital or acquired knee deformity;

• pregnant or lactating women;

• tumor patients;

• immunodeficiency patients;

• intra-articular drug injection history within 3 months;

• participating in other clinical trials;

• other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Mesenchymal Stem Cells from adipose
inject mesenchymal Stem Cells from adipose
• Hyaluronic Acid
inject hyaluronic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unexplained local and systemic symptoms or death	The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:?not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ?related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ?it can't be assessed.	2 years
Secondary	VAS score	VAS score decrease 3 points or more	2 years
Secondary	WOMAC score	two or more terms of WOMAC score have improvement.	2 years