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

Primary Purpose

Pulmonary Hypertension

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
adipose derived mesenchymal stem cells
Conventional drug therapy（expectorant，bronchodilator）
Sponsored by
Liaocheng People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary hypertension（PH）mesenchymal stem cells(MSC)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 -

Sites / Locations

  • Liaocheng city people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in Pulmonary Vascular Resistance from Baseline

Secondary Outcome Measures

Change from Baseline in Participant Quality of Life Using the SF-36
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
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)
To assess pre-specified laboratory assessment for change over time with treatment
Incidence of Treatment Adverse
An AE was any untoward medical occurrence in a participant
Change in Six Minute Walk distance
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

Full Information

First Posted
August 8, 2019
Last Updated
August 12, 2019
Sponsor
Liaocheng People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04055415
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liaocheng People's Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary hypertension（PH）mesenchymal stem cells(MSC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Other
Arm Description
The Conventional drug therapy（expectorant，bronchodilator） is used with the control group
Intervention Type
Biological
Intervention Name(s)
adipose derived mesenchymal stem cells
Intervention Description
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
Drug
Intervention Name(s)
Conventional drug therapy（expectorant，bronchodilator）
Intervention Description
Conventional drug therapy（expectorant，bronchodilator）
Primary Outcome Measure Information:
Title
Change in Pulmonary Vascular Resistance from Baseline
Time Frame
Baseline, 4, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Participant Quality of Life Using the SF-36
Description
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.
Time Frame
Baseline, 4, 12 and 24 weeks
Title
Change in Plasma NT-pro-BNP levels
Description
Plasma NT-proBNP concentration is a useful biomarker for PAH as it is associated with changes in right heart morphology and function.
Time Frame
Baseline, 4, 12 and 24 weeks
Title
Change in the IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 (ng/ul)
Description
To assess pre-specified laboratory assessment for change over time with treatment
Time Frame
Baseline, 4, 12 and 24 weeks
Title
Incidence of Treatment Adverse
Description
An AE was any untoward medical occurrence in a participant
Time Frame
Baseline, 4, 12 and 24 weeks
Title
Change in Six Minute Walk distance
Description
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
Time Frame
Baseline, 4, 12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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. - Exclusion Criteria: Patients with acute myocardial infarction and cardiac surgery in the past 1 month Surgery may be required within 8 weeks patients with prior pneumonectomy or having acute, chronic pulmonary embolism or other serious pulmonary diseases Having a history of malignant tumor Participated in other clinical investigators in the last 6 months To allergic to penicillin, gentamicin, aminoglycoside, human serum albumin and DMEM medium A woman who is planning to pregnancy, gestation, or lactation Other reasons caused Pulmonary hypertension and heart failure caused by other causes;Severe liver and kidney failure;Autoimmune diseases;Patients with infectious diseases According toThe researchers' judgments, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study According to the researcher's judgment, this study is not suitable for other conditions -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaoda Ren, Ph.D.
Phone
86-0635-8272202
Email
zslrsd@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shoudong Chai, Ph.D.
Phone
86-0635-8272204
Email
13666387867@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengjun Ma, M.D
Organizational Affiliation
Liaocheng People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Liaocheng city people's hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
0635
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoda Ren, Ph.D.
Phone
86-0635-8272202
Email
zslrsd@163.com

12. IPD Sharing Statement

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

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