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Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord

NCT ID: NCT03358654

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Umbilical Cord Bleeding Knee Osteoarthritis

Keywords

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Umbilical Cord Bleeding Knee Osteoarthritis stem cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mesenchymal stem cells

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

Group Type EXPERIMENTAL

mesenchymal stem cells from umbilical cord

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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yangziyi

arthritis clinic and research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianhao Lin, MD

Role: PRINCIPAL_INVESTIGATOR

arthritis clinic and research center

Central Contacts

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Ziyi Yang

Role: CONTACT

Phone: +86 18810335110

Email: [email protected]

Other Identifiers

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PUPH20170911

Identifier Type: -

Identifier Source: org_study_id