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

NCT ID: NCT04055415

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-02-01

Brief Summary

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

adipose derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

The MSCs of 1×10\*6/kg will be given in Central venous catheterization for injection at a total 100 ml (2) the experimental group was treated with conventional drug and adipose mesenchymal stem cell injection, and adipose MSCs were treated with central venous catheterization. The injection cycle was once every week of two times.Injection dose: 1×106 /kg.

Conventional drug therapy（expectorant，bronchodilator）

Intervention Type: DRUG

Conventional drug therapy（expectorant，bronchodilator）

Control group

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

Group Type: OTHER

Conventional drug therapy（expectorant，bronchodilator）

Intervention Type: DRUG

Conventional drug therapy（expectorant，bronchodilator）

Interventions

adipose derived mesenchymal stem cells

The MSCs of 1×10\*6/kg will be given in Central venous catheterization for injection at a total 100 ml (2) the experimental group was treated with conventional drug and adipose mesenchymal stem cell injection, and adipose MSCs were treated with central venous catheterization. The injection cycle was once every week of two times.Injection dose: 1×106 /kg.

Intervention Type: BIOLOGICAL

Conventional drug therapy（expectorant，bronchodilator）

Conventional drug therapy（expectorant，bronchodilator）

Intervention Type: DRUG

Eligibility Criteria

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.

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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 -

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaocheng People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shengjun Ma, M.D

Role: STUDY_CHAIR

Liaocheng People's Hospital

Locations

Liaocheng city people's hospital

Liaocheng, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shaoda Ren, Ph.D.

Role: CONTACT

zslrsd@163.com

86-0635-8272202

Shoudong Chai, Ph.D.

Role: CONTACT

13666387867@163.com

86-0635-8272204

Facility Contacts

Shaoda Ren, Ph.D.

Role: primary

zslrsd@163.com

86-0635-8272202

Other Identifiers

mashengjun2

Identifier Type: -

Identifier Source: org_study_id