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

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ClinicalTrials.gov Identifier: NCT04055415
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Liaocheng People's Hospital

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Biological: adipose derived mesenchymal stem cells Drug: Conventional drug therapy(expectorant,bronchodilator) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial Hypertension
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : February 1, 2021


Arm Intervention/treatment
Experimental: 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.
Biological: 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.

Drug: Conventional drug therapy(expectorant,bronchodilator)
Conventional drug therapy(expectorant,bronchodilator)

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




Primary Outcome Measures :
  1. Change in Pulmonary Vascular Resistance from Baseline [ Time Frame: Baseline, 4, 12 and 24 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in Participant Quality of Life Using the SF-36 [ Time Frame: 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.

  2. Change in Plasma NT-pro-BNP levels [ Time Frame: 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.

  3. Change in the IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 (ng/ul) [ Time Frame: Baseline, 4, 12 and 24 weeks ]
    To assess pre-specified laboratory assessment for change over time with treatment

  4. Incidence of Treatment Adverse [ Time Frame: Baseline, 4, 12 and 24 weeks ]
    An AE was any untoward medical occurrence in a participant

  5. Change in Six Minute Walk distance [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055415


Contacts
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Contact: Shaoda Ren, Ph.D. 86-0635-8272202 zslrsd@163.com
Contact: Shoudong Chai, Ph.D. 86-0635-8272204 13666387867@163.com

Locations
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China, Shandong
Liaocheng city people's hospital Recruiting
Liaocheng, Shandong, China, 0635
Contact: Shaoda Ren, Ph.D.    86-0635-8272202    zslrsd@163.com   
Sponsors and Collaborators
Liaocheng People's Hospital
Investigators
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Study Chair: Shengjun Ma, M.D Liaocheng People's Hospital

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Responsible Party: Liaocheng People's Hospital
ClinicalTrials.gov Identifier: NCT04055415     History of Changes
Other Study ID Numbers: mashengjun2
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Liaocheng People's Hospital:
Pulmonary hypertension(PH)mesenchymal stem cells(MSC)

Additional relevant MeSH terms:
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Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Expectorants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents