NCT03357770

The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord

Evaluating the Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Knee Osteoarthritis
• Umbilical Cord Bleeding

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-01
• Completion: 2021-06-01
• First posted: 2017-11-30
• Last updated: 2017-11-30