ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 804 for:    Interventional Studies | mesenchymal

Human Mesenchymal Stem Cells For Refractory Pulmonary Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03601416
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Xia Yunqiu, Children's Hospital of Chongqing Medical University

July 17, 2018
July 26, 2018
October 15, 2018
October 1, 2018
December 1, 2018   (Final data collection date for primary outcome measure)
Number of participants with adverse reactions after treatment [ Time Frame: 24 hours after administration ]
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for refractory pulmonary diseases.
Same as current
Complete list of historical versions of study NCT03601416 on ClinicalTrials.gov Archive Site
  • Changes of blood pressure in participants [ Time Frame: 24 hours after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for refractory pulmonary diseases. Blood pressure is measured by electronic sphygmomanometer .
  • Changes of heart rate in participants [ Time Frame: 24 hours after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for refractory pulmonary diseases.
Same as current
  • Changes of respiratory rate in participants [ Time Frame: 24 hours after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for refractory pulmonary diseases.
  • Changes of high-resolution chest CT in participants [ Time Frame: within 2 years after administration ]
    To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for refractory pulmonary diseases.
Same as current
 
Human Mesenchymal Stem Cells For Refractory Pulmonary Diseases
Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Refractory Pulmonary Diseases in Children
This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in children for refractory pulmonary diseases.

Refractory pulmonary diseases include bronchopulmonary dysplasia (BPD),acute respiratory distress syndrome(ARDS),pulmonary fibrosis (PF) and Bronchiolitis obliterans(BO) with high mortality and poor prognosis,and there are still lack of effective therapies to prevent or treat these diseases.

hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So,the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants with refractory pulmonary diseases.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Refractory Pulmonary Diseases
  • Drug: Transplantation of mesenchymal stem cell

    Human umbilical cord-derived mesenchymal stem cell will be given to participants through intravenous infusion.

    Dose A - 1 million cells per kg Dose B - 5 million cells per kg

  • Drug: No Transplantation of Mesenchymal Stem Cell
    Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.
  • Experimental: Transplantation of Mesenchymal Stem Cell
    Mesenchymal stem cell will be given to participants with refractory pulmonary diseases.
    Intervention: Drug: Transplantation of mesenchymal stem cell
  • Active Comparator: No Transplantation of Mesenchymal Stem Cell
    Mesenchymal stem cell will be not given to participants with refractory pulmonary diseases.
    Intervention: Drug: No Transplantation of Mesenchymal Stem Cell

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
December 31, 2020
December 1, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Participants with refractory pulmonary diseases are not well treated by routine therapy
  2. The legal representative or the participant had signed consent.

Exclusion Criteria:

  • 1. Severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, III-IV grade pulmonary hypertension, Lung transplantation, current indications of acute surgery after lung transplantation) 2. Family and child (> 14 years) refuse to sign consent
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact: Yunqiu Xia 023-63622066 sunny_199001@foxmail.com
Contact: Lin Zou 023-63622066
China
 
 
NCT03601416
Xia Yunqiu
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Xia Yunqiu, Children's Hospital of Chongqing Medical University
Children's Hospital of Chongqing Medical University
Not Provided
Study Chair: Zhou Fu Children's Hospital of Chongqing Medical University
Children's Hospital of Chongqing Medical University
July 2018