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

NCT04062136 | Completed Phase 1 DMC

• 1 other identifier: VinmecISC1915
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary dysplasia; umbilical cord mesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

• Adverse events and serious adverse events

  Incidence of the adverse events or serious adverse events after transplantation

  during 9 months post treatment

• The proportion of patients win from oxygen

  To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation.

  during 9 months post treatment

Secondary Outcomes (1)

• The lung fibrosis

  at 6 months post treatment

Study Arms (1)

Stem cell transplantation

EXPERIMENTAL

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

Combination Product: stem cell transplantation

Interventions

stem cell transplantation COMBINATION_PRODUCT

Transplantation of umbilical cord mesenchymal stem cells

Stem cell transplantation

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

Location

Related Publications (3)

• 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.

  PMID: 23364976 RESULT

• 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.

  PMID: 24508444 RESULT

• 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.

  PMID: 29021519 RESULT

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: August 20, 2019
• Study Start: March 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)