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Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord

P

Peking University

Status

Unknown

Conditions

Umbilical Cord Bleeding
Knee Osteoarthritis

Treatments

Drug: mesenchymal stem cells from umbilical cord

Study type

Interventional

Funder types

Other

Identifiers

NCT03358654
PUPH20170911

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -

Exclusion criteria

① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases. -

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

mesenchymal stem cells
Experimental group
Description:
Inject mesenchymal stem cells from umbilical cord. The patients will be followed up at 1, 2, 3, and 6 months after the injection
Treatment:
Drug: mesenchymal stem cells from umbilical cord

Trial contacts and locations

0

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Central trial contact

Ziyi Yang

Data sourced from clinicaltrials.gov

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