Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

Hebei Medical University

Status and phase: Unknown; Phase 1

Conditions: Aplastic Anemia

Treatments: Biological: mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03055078

17277787D-AA

Details and patient eligibility

About

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

Full 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 .

Enrollment: 10 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

mesenchymal stem cells

Experimental group

Description:

According to the inclusion and exclusion criteria, selected patients were divided into a cell therapy group and a control group. Umbilical cord derived mesenchymal stem cells at a dose of 100-300 million by intravenous infusion.

Treatment:

Biological: mesenchymal stem cells