Clinical trial NCT04055415: Clinical Study of Adipose Derived Mesenchymal Stem Cells for Treatment of Pulmonary Arterial Hypertension
Official title: Safety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension（PH）mesenchymal stem cells(MSC)
Lead sponsor: Liaocheng People's Hospital
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 -

Primary outcomes:
measure: Change in Pulmonary Vascular Resistance from Baseline
timeFrame: Baseline, 4, 12 and 24 weeks
Secondary outcomes:
measure: Change from Baseline in Participant Quality of Life Using the SF-36
timeFrame: Baseline, 4, 12 and 24 weeks
measure: Change in Plasma NT-pro-BNP levels
timeFrame: Baseline, 4, 12 and 24 weeks
measure: Change in the IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 (ng/ul)
timeFrame: Baseline, 4, 12 and 24 weeks
measure: Incidence of Treatment Adverse
timeFrame: Baseline, 4, 12 and 24 weeks
measure: Change in Six Minute Walk distance
timeFrame: Baseline, 4, 12 and 24 weeks
Other outcomes:
Locations:
city: Liaocheng
country: China
facility: Liaocheng city people's hospital
state: Shandong
Study officials:
affiliation: Liaocheng People's Hospital
name: Shengjun Ma, M.D
role: STUDY_CHAIR
References: