Pulmonary Hypertension
Conditions
Keywords
Pulmonary hypertension（PH）mesenchymal stem cells(MSC)
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.
Interventions
BIOLOGICALadipose 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.
DRUGConventional drug therapy（expectorant，bronchodilator）
Conventional drug therapy（expectorant，bronchodilator）
Sponsors
Liaocheng People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pulmonary Vascular Resistance from Baseline | Baseline, 4, 12 and 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Participant Quality of Life Using the SF-36 | Baseline, 4, 12 and 24 weeks | Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which are combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life. |
| Change in Plasma NT-pro-BNP levels | Baseline, 4, 12 and 24 weeks | Plasma NT-proBNP concentration is a useful biomarker for PAH as it is associated with changes in right heart morphology and function. |
| Change in the IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 (ng/ul) | Baseline, 4, 12 and 24 weeks | To assess pre-specified laboratory assessment for change over time with treatment |
| Incidence of Treatment Adverse | Baseline, 4, 12 and 24 weeks | An AE was any untoward medical occurrence in a participant |
| Change in Six Minute Walk distance | Baseline, 4, 12 and 24 weeks | The 6MWD is a 6 minute walk test. This test, a measure of exercise capacity, assesses the distance that a subject can walk in a period of 6 minutes |
Countries
China
Contacts
Primary ContactShaoda Ren, Ph.D.
Backup ContactShoudong Chai, Ph.D.
Outcome results
None listed