The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord

Peking University

Status

Unknown

Conditions

Umbilical Cord Bleeding

Knee Osteoarthritis

Treatments

Drug: mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03357770

PUPH20170910

Details and patient eligibility

About

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

Full 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.

Enrollment

9 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.-

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

9 participants in 3 patient groups

low dose of mesenchymal stem cells

Experimental group

Description:

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

Treatment:

Drug: mesenchymal stem cells

medium dose of mesenchymal stem cells

Experimental group

Description:

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

Treatment:

Drug: mesenchymal stem cells

high dose of mesenchymal stem cells

Experimental group

Description:

the high dose is 1 × 10\^8cells / 3mL