Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord

November 25, 2017 updated by: yangziyi, Peking University People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unexplained local and systemic symptoms or death
Time Frame: 6 months
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:①not 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); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Jianhao Lin, MD, arthritis clinic and research center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 25, 2017

First Submitted That Met QC Criteria

November 25, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 25, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUPH20170911

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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