Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients

Summary

This clinical trial is a clinical trial for the evaluation of the safety and efficacy of umbilical cord blood (UCB) therapy, UCB and erythropoietin (EPO) combination therapy in adult stroke patients.

Conditions

• Stroke
• Umbilical Cord Blood
• Erythropoietin
• Safety
• Treatment Outcome

Interventions

DRUG

Umbilical cord blood infusion

The umbilical cord blood is donated umbilical cord blood which is stored in the cord blood bank donated by Cha Hospital. The total number of nuclear cells should be at least 2 x 10 7 / kg, and at least three out of six of the six human leukocyte antigens (HLA-A, B, DR) should be selected. The cord blood that matches ABO and Rh blood type is preferentially used. Umbilical cord blood infusion is administered intravenously and is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.

DRUG

Erythropoietin injection

Recombinant human erythropoietin is used and is administered intravenously at a maximum of 5 times at a rate of 500 IU / kg 2 times/week after cord blood peripheral blood infusion, calculated as the dose per body weight. Or subcutaneous administration if intravenous administration is not possible. Store in a sealed container at 2-8 °C in the refrigerator before dosing. Erythropoietin injection is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.

DRUG

Placebo umbilical cord blood infusion

Placebo umbilical cord blood infusion is administered intravenously and is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.

DRUG

Placebo erythropoietin injection

Placebo erythropoietin injection is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.

PROCEDURE

Active rehabilitation

Physical therapy and occupational therapy are performed daily.

Sponsors & Collaborators

• Korea Evaluation Institute of Industrial Technology

  collaborator OTHER

• Bundang CHA Hospital

  lead OTHER

Principal Investigators

• MinYoung Kim, MD,PhD · CHA Bundang Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-02

Primary Completion

2020-11-02

Completion

2021-11-02

Countries

• South Korea

Study Locations