Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord

Knee Osteoarthritis Clinical Trial

Official title:

Evaluating the Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord in the Treatment of Knee Joint Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03358654
• Other study ID #: PUPH20170911
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: November 25, 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
• Phone: +86 18810335110
• Email: bjmuyangziyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and systemic symptoms or death before and at 1, 2, 3, 6 months after the injection.

Description:

This is a single group assignment study with a total of 9 knee osteoarthritis patients participants. All of the patients will receive the anticular injection with MSCs from umbilical cord and unexplained local and systemic symptoms or death before the end of following-up will be assessed to evaluate the safety and efficacy of mesenchymal stem cells from umbilical cord.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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

• Hemorrhage
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Umbilical Cord Bleeding

Intervention

Drug:
• mesenchymal stem cells from umbilical cord
inject mesenchymal stem cells from umbilical cord,and the patients will be followed up at 1, 2, 3, and 6 months after the injection.

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.	6 months