IUMTB: Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)

• Sponsor: Children's Hospital of Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03645525
• Collaborator: (none)
• Enrollment: 180
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 40
• Patients Per Site: 60
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Condition or Disease	Intervention/Treatment	Phase
Bronchopulmonary Dysplasia	Drug: Human Umbilical Cord-derived Mesenchymal stem cell; Drug: placebo	Phase 1/Phase 2

Detailed Description

Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
• Actual Study Start Date: Dec 1, 2019
• Anticipated Primary Completion Date: Oct 30, 2022
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mesenchymal stem cell Human Umbilical Cord-derived Mesenchymal stem cell in the saline	Drug: Human Umbilical Cord-derived Mesenchymal stem cell; The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube
Placebo Comparator: placebo saline without mesenchymal stem cell	Drug: placebo; saline

Outcome Measures

Primary Outcome Measures

1. Oxygen requirement 3 days after transplantation [3 days]

   Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %

Secondary Outcome Measures

1. Oxygen requirement 7 days after transplantation [7 days]

   Temporal profiles of the fraction of inspiration oxygen 7 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %

2. Duration of ventilator dependence [up to 36 weeks PMA]

   The duration from transplantation to weaning from ventilator

3. Incidence of severe BPD [up to 36 weeks PMA]

   percentage of participants with severe BPD ,diagnosed at 36 weeks PMA

4. Survival rate [up to 36 weeks PMA]

   Percentage of participants who survived up to 36 weeks PMA

5. Temperature [3 days]

   Temporal profiles of temperature

6. Heart rate [3 days]

   Temporal profiles of heart rate

7. Respiratory rate [3 days]

   Temporal profiles of respiratory rate

8. Duration of CPAP treatment [up to 36 weeks PMA]

   Duration of CPAP treatment

9. Percentage of participants treated with steroids for weaning from ventilator [up to 36 weeks PMA]

   Percentage of participants treated with steroids for weaning from ventilator

10. Growth velocity (Z-score) [up to 36 weeks PMA]

    percentile for body weight, height, and head circumference

11. bronohoalveolar lavage (BAL) cytokine level [7 days]

    BAL were collected 7 days after transplantation for cytokine (IL-6，IL-8，TNF-α，TGF-β,VEGF,HGF) level examination, measured in pg/ml

12. The severity of BPD in X-ray patterns [7 days]

    A chest X-ray was performed in participants before and after transplantation. The severity of BPD (mild，moderate，severe) was assessed by a single radiographic doctor who is blind about randomization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Weeks to 3 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age

• Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age

Exclusion Criteria:

• Patients with severe congenital diseases

• Patients with IVH more than 3 grade

• Patients with severe sepsis

• Patients with active pulmonary hemorrhage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai	China	200011
2	Children's Hospital of Fudan University	Shanghai	Shanghai	China	201102
3	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai	China	201204

Sponsors and Collaborators

• Children's Hospital of Fudan University

Investigators

• Study Director: Chen Chao, PhD,MD, Chiledren's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT03645525
• Other Study ID Numbers: EKYYIUMTB
• First Posted: Aug 24, 2018
• Last Update Posted: Sep 9, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Children's Hospital of Fudan University: Bronchopulmonary Dysplasia; Mesenchymal stem cell
• Additional relevant MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia

Study Results

No Results Posted as of Sep 9, 2021