Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

Aplastic Anemia Clinical Trial

Official title:

Evaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03055078
• Other study ID #: 17277787D-AA
• Status: Recruiting
• Phase: Phase 1
• First received: February 4, 2017
• Last updated: April 6, 2017
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: April 2017
• Source: Hebei Medical University
• Contact: Jun Zhang, Master
• Phone: 86-311-85917384
• Email: june_luck[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.

Description:

Aplastic anemia (AA) is a disorder thought to be caused by an immune-mediated bone marrow failure. Not all people with AA are eligible for today's standard treatments. One new treatment approach uses umbilical cord derived mesenchymal stem cells—specialized cells capable of developing into other types of cells—to provide the basis for clinical application. The aim of the present study is to investigate the safety and efficacy of vein infusion of allogeneic mesenchymal stem cells in patients with AA .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of AA according to established criteria in 2010

2. Age from 14 to 60 years

3. Suffering from AA within six months

4. No serious infection or acute hemorrhage.

5. Left ventricular ejection fraction (LVEF) = 50%

6. No acute infectious diseases.

7. Understanding and willingness to sign a written informed consent document.

8. Eastern Cooperative Oncology Group(ECOG) score of 0-2pionts.

Exclusion Criteria:

• Patients with AA have to be disqualified from this study if any of the following is applicable.

1. Severe aplastic anemia(SAA) with severe infection.

2. Severe aplastic anemia(SAA) with active hemorrhage.

3. Severe heart attack, liver and kidney disease following serious complications

4. Patients with allergic constitution.

5. Pregnancy and lactation.

6. Accompanied by malignant tumors and other clonal disease.

7. Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Aplastic Anemia

Intervention

Biological:
• mesenchymal stem cells
Patients in the cell treated group were given umbilical cord derived mesenchymal stem cells by intravenous infusion besides conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1months, 3months, 6months and 9months were evaluated respectively the therapeutic effect.

Locations

Country	Name	City	State
China	the First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin levels in peripheral blood	The recovery of bone marrow erythrocyte is evaluated by hemoglobin levels (g/L) in peripheral blood.	Post cell transplantation: 9months
Secondary	The number of red blood cell in peripheral blood	The improvement of bone marrow erythrocyte is evaluated by red blood cell count (×10^12/L) in peripheral blood.	Post cell transplantation: 1, 3, 6, 9months
Secondary	The number of granulocyte in peripheral blood	The recovery of bone marrow granulocyte is evaluated by granulocyte count (×10^9/L) in peripheral blood.	Post cell transplantation: 1, 3, 6, 9months
Secondary	The number of white blood cell in peripheral blood	The improvement of bone marrow granulocyte is evaluated by white blood cell count (×10^9/L) in peripheral blood.	Post cell transplantation: 1, 3, 6, 9months
Secondary	The evaluation of bone marrow megakaryocytic series	The status of megakaryocytic series is evaluated by platelet count (×10^9/L) in peripheral blood.	Post cell transplantation: 1, 3, 6, 9months
Secondary	adverse reaction	Adverse reaction includes temperature changes(?), the change of blood pressure(mmHg) and allergic reaction.	Post cell transplantation: 1, 3, 6, 9months