Clinical Study of Adipose Derived Mesenchymal Stem Cells for Treatment of Pulmonary Arterial Hypertension

Liaocheng People's Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pulmonary Hypertension

Treatments: Biological: adipose derived mesenchymal stem cells; Drug: Conventional drug therapy（expectorant，bronchodilator）

Study type: Interventional

Funder types: Other

Identifiers

NCT04055415

mashengjun2

Details and patient eligibility

About

Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.Mesenchymal stem cells (MSCs)are a subset of adult stem cells residing in many tissues, including bone marrow(BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues.It was found that MSCs can significantly improve the pulmonary hemodynamics, lung tissue gross and decrease the pulmonary artery pressure, middle artery thickness and right cardiac hypertrophy by intravenous injection.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

（1）40-75years （2）Male or female （3）The patients that COPD with moderate to severe pulmonary hypertension (pulmonary systolic pressure more than 40mmHg)in relatively stable period （4）To preliminary assess the Patients'lifetime have more than 6 months （5）According to the researchers' judgment, they can abide by the research protocol or Volunteer to participate in the clinical study, understand the study procedure and sign the informed consent in person.

Exclusion criteria

1. Patients with acute myocardial infarction and cardiac surgery in the past 1 month
2. Surgery may be required within 8 weeks
3. patients with prior pneumonectomy or having acute, chronic pulmonary embolism or other serious pulmonary diseases
4. Having a history of malignant tumor
5. Participated in other clinical investigators in the last 6 months
6. To allergic to penicillin, gentamicin, aminoglycoside, human serum albumin and DMEM medium
7. A woman who is planning to pregnancy, gestation, or lactation
8. Other reasons caused Pulmonary hypertension and heart failure caused by other causes;Severe liver and kidney failure;Autoimmune diseases;Patients with infectious diseases
9. According toThe researchers' judgments, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study
10. According to the researcher's judgment, this study is not suitable for other conditions -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention group

Experimental group

Description:

The MSCs of 1×10\*6/kg will be given in Central venous catheterization for injection at a total 100 ml . Once every week#a total of two times. The Conventional drug therapy（expectorant，bronchodilator） is used.

Treatment:

Biological: adipose derived mesenchymal stem cells

Drug: Conventional drug therapy（expectorant，bronchodilator）

Control group

Other group

Description:

The Conventional drug therapy（expectorant，bronchodilator） is used with the control group

Treatment:

Drug: Conventional drug therapy（expectorant，bronchodilator）