Study assesses stem cells’ capacity to forestall significant reason for death in preterm newborn

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• Source: AlphaMed Press


• Date: 21 Apr,2021

A phase 2 clinical trial whose results were published today in STEM CELLS Translational Medicine might point to a way to conquer bronchopulmonary dysplasia (BPD), a significant cause of death in preterm infants. The study, conducted by researchers at Samsung Medical Center, Sungkyunkwan University and Asan Medical Center Children’s Hospital in Seoul, evaluates the efficacy of treating these infants by transplanting umbilical cord blood-derived mesenchymal stem cells (UCB-MSCs) directly in their tracheas.

BPD is a serious breathing disorder in which the lungs do not develop normally. Most infants who develop BPD are born more than 10 weeks before their due date, weigh less than two pounds at birth, and have breathing problems. Infections that occur before or shortly after birth also can lead to the disorder. Despite recent advances in neonatal medicine, BPD remains a major cause of mortality and long-term respiratory and neurologic problems in premature infants.

Therefore, the two were co-authors of the current analysis, which was a double-blind randomized, placebo-controlled phase II clinical trial designed specifically to learn whether human UCB-derived MSC intratracheal transplantation might mitigate BPD in extremely preterm infants.

Choosing the optimal MSCs for transplantation was also a critical point of the work, added Dr. Kim. “We concentrated on UCB-MSCs, since they exhibit several advantages over adult tissue-derived MSCs, including lower immunogenicity, greater proliferation capacity, paracrine potency and therapeutic efficacy both in vitro and in vivo,” she said. “Moreover, allogenic transplantation of MSCs, which come from a donor as opposed to the patient, might have a logistic advantage as they can be used at an early active stage of disease.”

While intratracheal transplantation of human UCB-derived MSCs has proven to be safe and feasible in recently conducted clinical trials, its therapeutic efficacy had not been assessed in a clinical setting prior to this study.”

Won Soon Park, M.D., Ph.D., of Samsung Medical Center and Sungkyunkwan University School of Medicine

All were on ventilators and each also had experienced significant respiratory problems between five and 14 days after birth. The infants were then assessed for six months.

In their final analysis, the team confirmed that intratracheal transplantation of MSCs appears to be safe and feasible.

“At the same time, we heard that MSC transplantation didn’t significantly improve the primary outcome of death or severe/moderate BPD in babies in the 25-28 GW group. However, our subgroup analysis showed that the secondary outcome of severe BPD was significantly improved – dropping from 53 percent to 19 percent – from the younger 23-24 GW group,” Dr. Park said.

Dr. Kim added,”Further study with a larger sample size is needed to prove therapeutic benefits for infants in this group who are at the highest risk for BPD or death. Accordingly, we are currently conducting an additional larger and controlled phase II clinical trial focusing on 23-24 GW babies. We expect to publish these data in the near future.”

“This study suggests that the transplantation of umbilical cord blood-derived mesenchymal stem cells directly into the tracheas of preterm babies might mitigate their breathing challenges,” said Anthony Atala, M.D., Editor-in-Chief of STEM CELLS Translational Medicine and Director of the Wake Forest Institute for Regenerative Medicine. “The data are reassuring and useful and should result in a bigger, future clinical trial”