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

NCT04055415 | Unknown Phase 1

• 1 other identifier: mashengjun2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertension（PH）mesenchymal stem cells(MSC)

Outcome Measures

Primary Outcomes (1)

• Change in Pulmonary Vascular Resistance from Baseline

  Baseline, 4, 12 and 24 weeks

Secondary Outcomes (5)

• Change from Baseline in Participant Quality of Life Using the SF-36

  Baseline, 4, 12 and 24 weeks

• Change in Plasma NT-pro-BNP levels

  Baseline, 4, 12 and 24 weeks

• Change in the IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 (ng/ul)

  Baseline, 4, 12 and 24 weeks

• Incidence of Treatment Adverse

  Baseline, 4, 12 and 24 weeks

• Change in Six Minute Walk distance

  Baseline, 4, 12 and 24 weeks

Study Arms (2)

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.

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

Drug: Conventional drug therapy（expectorant，bronchodilator）

Interventions

adipose derived mesenchymal stem cells BIOLOGICAL

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 group

Conventional drug therapy（expectorant，bronchodilator） DRUG

Conventional drug therapy（expectorant，bronchodilator）

Control group; Intervention group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• （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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Liaocheng People's Hospital: lead

Study Sites (1)

Liaocheng city people's hospital

Liaocheng, Shandong, 0635, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shengjun Ma, M.D

  Liaocheng People's Hospital

  STUDY CHAIR

Central Study Contacts

Shaoda Ren, Ph.D.

CONTACT

86-0635-8272202; zslrsd@163.com

Shoudong Chai, Ph.D.

CONTACT

86-0635-8272204; 13666387867@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CN (1)