The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord

Not Applicable

• Conditions: Knee Osteoarthritis; Umbilical Cord Bleeding
• Interventions: Drug: mesenchymal stem cells

• Registration Number: NCT03357770
• Lead Sponsor: Peking University People's Hospital

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

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 Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-25
• Last Update Submitted: 2017-11-25
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Study Start: 2018-01-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medium dose of mesenchymal stem cells	mesenchymal stem cells	the medium-dose is 5 × 10\^7cells / 3mL
low dose of mesenchymal stem cells	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
high dose of mesenchymal stem cells	mesenchymal stem cells	the high dose is 1 × 10\^8cells / 3mL

Primary Outcome Measures

Name	Time	Method
Unexplained local and systemic symptoms or death	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.