Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia

• ClinicalTrials.gov Identifier: NCT04062136
• Recruitment Status: Unknown
• First Posted: August 20, 2019
• Last Update Posted: August 20, 2019
• Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
• Information provided by (Responsible Party): Vinmec Research Institute of Stem Cell and Gene Technology

Tracking Information

• First Submitted Date: March 27, 2019
• First Posted Date: August 20, 2019
• Last Update Posted Date: August 20, 2019
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2019)

• Adverse events and serious adverse events [ Time Frame: during 9 months post treatment ]
  Incidence of the adverse events or serious adverse events after transplantation
• The proportion of patients win from oxygen [ Time Frame: during 9 months post treatment ]
  To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 19, 2019)

The lung fibrosis [ Time Frame: at 6 months post treatment ]

Changes of the lung fibrosis on chest CT at 6 months compared with baseline

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
• Official Title: Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
• Brief Summary: To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia
• Detailed Description: The purpose of this study is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in 10 patients with bronchopulmonary dysplasia at Vinmec International Hospital, Hanoi, Vietnam
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Bronchopulmonary Dysplasia

Intervention

Combination Product: stem cell transplantation

Transplantation of umbilical cord mesenchymal stem cells

Study Arms

Experimental: Stem cell transplantation

1 million umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 1 week after the first transplantation

Intervention: Combination Product: stem cell transplantation

Publications *

• Ahn SY, Chang YS, Kim SY, Sung DK, Kim ES, Rime SY, Yu WJ, Choi SJ, Oh WI, Park WS. Long-term (postnatal day 70) outcome and safety of intratracheal transplantation of human umbilical cord blood-derived mesenchymal stem cells in neonatal hyperoxic lung injury. Yonsei Med J. 2013 Mar 1;54(2):416-24. doi: 10.3349/ymj.2013.54.2.416.
• Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6.
• Liem NT, Anh TL, Thai TTH, Anh BV. Bone Marrow Mononuclear Cells Transplantation in Treatment of Established Bronchopulmonary Dysplasia: A Case Report. Am J Case Rep. 2017 Oct 12;18:1090-1094. doi: 10.12659/ajcr.905244.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 19, 2019): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2020
• Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• The patient is diagnosis Bronchopulmonary Dysplasia (premature and depends on oxygen until 28 days old
• Gender: either sex
• Year old < 6 months
• Weight ≥ 2 kg
• Agree to participate in the study.

Exclusion Criteria:

• Severe congenital malformation.
• Other severe conditions (active pulmonary bleeding, evidence of active infections).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Month to 6 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Vietnam

Administrative Information

• NCT Number: NCT04062136
• Other Study ID Numbers: VinmecISC1915
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
• Original Responsible Party: Same as current
• Current Study Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Vinmec Research Institute of Stem Cell and Gene Technology
• Verification Date: August 2019