The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord

NCT ID: NCT03357770

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

2021-06-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Knee Osteoarthritis Umbilical Cord Bleeding

Keywords

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mesenchymal stem cells Knee Osteoarthritis Umbilical Cord

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

mesenchymal stem cells

Intervention Type DRUG

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

medium dose of mesenchymal stem cells

the medium-dose is 5 × 10\^7cells / 3mL

Group Type EXPERIMENTAL

mesenchymal stem cells

Intervention Type DRUG

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

high dose of mesenchymal stem cells

the high dose is 1 × 10\^8cells / 3mL

Group Type EXPERIMENTAL

mesenchymal stem cells

Intervention Type DRUG

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

Interventions

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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

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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PUPH20170910

Identifier Type: -

Identifier Source: org_study_id