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The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord

NCT03357770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-11-30

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Jianhao Lin, MD · arthritis clinic and research center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-12-01
Completion
2021-06-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03357770 on ClinicalTrials.gov