Clinical trial NCT03055078: Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia
Official title: Evaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aplastic Anemia
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin levels in peripheral blood
timeFrame: Post cell transplantation: 9months
Secondary outcomes:
measure: The number of red blood cell in peripheral blood
timeFrame: Post cell transplantation: 1, 3, 6, 9months
measure: The number of granulocyte in peripheral blood
timeFrame: Post cell transplantation: 1, 3, 6, 9months
measure: The number of white blood cell in peripheral blood
timeFrame: Post cell transplantation: 1, 3, 6, 9months
measure: The evaluation of bone marrow megakaryocytic series
timeFrame: Post cell transplantation: 1, 3, 6, 9months
measure: adverse reaction
timeFrame: Post cell transplantation: 1, 3, 6, 9months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Baoyong Yan, Doctor
role: STUDY_CHAIR
affiliation: The First Hospital of Hebei Medical University
name: Qingchi Liu, Doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Quanhai Li, Doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Xiaohui Jia, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Xianyun Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Fan Zhang, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Yang Shen, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Bing Ma, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Wanyi Yin, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Dan Zhao, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Bojian Sun, Master
role: PRINCIPAL_INVESTIGATOR
References: