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The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord

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ClinicalTrials.gov Identifier: NCT03357770
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
yangziyi, Peking University People's Hospital

Study Description
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Brief Summary:
The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of human knee OA

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Umbilical Cord Bleeding Drug: mesenchymal stem cells Not Applicable

Detailed Description:
This is a single-centre, quadruple blined, randomized controlled trail with a total of 9 knee osteoarthrits patients as participants, who will be randomly assigned into high dose group, moderate dose group or low dose group. The participants in the high dose group will receive the treatment of high dose MSCs (1×10^8cells/3mL) anticular injection.The dose of the MSCs in medium dose group is 5×10^7cells/3mL, and the dose in the low dose group is 1×10^7cells/3mL. Unexplained local and systemic symptoms will be assessed to determine the the maximum tolerated dose of mesenchymal stem cells in anticular injection.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: low dose of mesenchymal stem cells
Three groups of patients were enrolled in this study. Every group includes three patients. The three groups of patients were treated with high, medium and low dose of cytokine.The low-dose is 1 × 10^7cells / 3mL
 Drug: mesenchymal stem cells
we will enroll three groups of patients, and they will be therapized by high, medium, and low-dose cytotoxic respectively to evaluate the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD). Dose and cell concentration selection will be based on previous literature [5]. The low-dose is 1 × 10^7cells / 3mL, the medium-dose is 5 × 10^7cells / 3mL and the high dose is 1 × 10^8cells / 3mL
Experimental: medium dose of mesenchymal stem cells
the medium-dose is 5 × 10^7cells / 3mL
 Drug: mesenchymal stem cells
we will enroll three groups of patients, and they will be therapized by high, medium, and low-dose cytotoxic respectively to evaluate the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD). Dose and cell concentration selection will be based on previous literature [5]. The low-dose is 1 × 10^7cells / 3mL, the medium-dose is 5 × 10^7cells / 3mL and the high dose is 1 × 10^8cells / 3mL
Experimental: high dose of mesenchymal stem cells
the high dose is 1 × 10^8cells / 3mL
 Drug: mesenchymal stem cells
we will enroll three groups of patients, and they will be therapized by high, medium, and low-dose cytotoxic respectively to evaluate the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD). Dose and cell concentration selection will be based on previous literature [5]. The low-dose is 1 × 10^7cells / 3mL, the medium-dose is 5 × 10^7cells / 3mL and the high dose is 1 × 10^8cells / 3mL


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.-

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357770


Contacts
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Contact: Ziyi Yang +86 18810335110 bjmuyangziyi@163.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Jianhao Lin, MD arthritis clinic and research center
More Information
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Responsible Party: yangziyi, arthritis clinic and research center, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03357770     History of Changes
Other Study ID Numbers: PUPH20170910
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by yangziyi, Peking University People's Hospital:
mesenchymal stem cells
Knee Osteoarthritis
Umbilical Cord

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases