Pulmonary HypertensionPhase 1/2NCT04055415
Clinical Study of Adipose Derived Mesenchymal Stem Cells for Treatment of Pulmonary Arterial Hypertension
A Phase 1/2 study testing adipose derived mesenchymal stem cells and Conventional drug therapy（expectorant，bronchodilator） in people with Pulmonary Hypertension, run by Liaocheng People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- adipose derived mesenchymal stem cells and Conventional drug therapy（expectorant，bronchodilator）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Feb 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- （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.
- -
Who cannot join
- 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
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- 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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaocheng city people's hospital
Liaocheng, Shandong, 0635
Shaoda Ren, Ph.D., 86-0635-8272202, zslrsd@163.com
About this study
Official title: Safety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial Hypertension
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
- Being tested
- adipose derived mesenchymal stem cells, Conventional drug therapy（expectorant，bronchodilator）
- Keywords
- Pulmonary hypertension（PH）mesenchymal stem cells(MSC)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose derived mesenchymal stem cellsBiological
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）Drug
Conventional drug therapy（expectorant，bronchodilator）
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Biological: adipose derived mesenchymal stem cells; Drug: Conventional drug therapy（expectorant，bronchodilator） |
| Control group | Other | The Conventional drug therapy（expectorant，bronchodilator） is used with the control group Receives: Drug: Conventional drug therapy（expectorant，bronchodilator） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Vascular Resistance from Baseline
Measured: Baseline, 4, 12 and 24 weeks
Secondary outcomes (5)
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.
Measured: Baseline, 4, 12 and 24 weeks
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.
Measured: Baseline, 4, 12 and 24 weeks
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
Measured: Baseline, 4, 12 and 24 weeks
Incidence of Treatment Adverse
An AE was any untoward medical occurrence in a participant
Measured: Baseline, 4, 12 and 24 weeks
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
Measured: Baseline, 4, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaocheng People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shengjun Ma, M.D, Study chair, Liaocheng People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055415
- Sponsor's protocol ID
- mashengjun2
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04055415
- Acronym / sponsor ID
- mashengjun2
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension（PH）mesenchymal stem cells(MSC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liaocheng People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: adipose derived mesenchymal stem cells, Drug: Conventional drug therapy（expectorant，bronchodilator）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. |
| Control group | Other | Drug: Conventional drug therapy（expectorant，bronchodilator）The Conventional drug therapy（expectorant，bronchodilator） is used with the control group |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- （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.
- -
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adipose derived mesenchymal stem cellsThe 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. | Biological | Intervention group |
| Conventional drug therapy（expectorant，bronchodilator）Conventional drug therapy（expectorant，bronchodilator） | Drug | Control group, Intervention group |
Primary outcome
Change in Pulmonary Vascular Resistance from Baseline
Time frame: Baseline, 4, 12 and 24 weeks
5 secondary outcomes
Change from Baseline in Participant Quality of Life Using the SF-36
Time frame: Baseline, 4, 12 and 24 weeks
Change in Plasma NT-pro-BNP levels
Time frame: Baseline, 4, 12 and 24 weeks
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
Incidence of Treatment Adverse
Time frame: Baseline, 4, 12 and 24 weeks
Change in Six Minute Walk distance
Time frame: Baseline, 4, 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengjun Ma, M.D study chair
Liaocheng People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing adipose derived mesenchymal stem cells and Conventional drug therapy（expectorant，bronchodilator） in people with Pulmonary Hypertension, run by Liaocheng People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaoda Ren, Ph.D. (86-0635-8272202, zslrsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulmonary Vascular Resistance from Baseline (time frame: Baseline, 4, 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.