Level B· Emerging clinical evidence with positive signalsRandomized Controlled TrialPubMedOpen access

Short- and Medium-Term Surgical Outcomes of Tissue-Engineered Pulmonary Valve Replacement in Sheep.

Al Hussein H., Al Hussein H., Suciu H., Anitei DE., Sircuta C., Cotfas I.

Randomized Controlled Trial with a reported sample of 10 on Cardiovascular Disease, published in Tissue Eng Regen Med (2025) — summary generated from the PubMed abstract.

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Level B· Emerging clinical evidence with positive signalsEvidence level of this study

Several human studies show positive signals, while research methods and sample sizes continue to develop.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
Read the A–D evidence level guide

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Randomized Controlled Trial
Journal
Tissue Eng Regen Med (2025)
Country
Korea (South)
Reported sample size
10
Source database
PubMed
PMID
40622599
PMCID
PMC12476344
DOI
10.1007/s13770-025-00735-8

Abstract (original English)

Background Tissue-engineered pulmonary valves (TEPVs) hold considerable potential for improving outcomes in valve replacement surgeries. We investigated the surgical outcomes of TEPVs replacement in sheep, specifically examining the effects of valve type (decellularized versus adipose-derived stem cell-seeded valve [ADSC]) and the animal's age at the surgery. The primary goals were to assess survival rates, postoperative complications, and the effects of cardiopulmonary bypass (CPB) on homeostasis. Methods Nineteen juvenile and adult sheep were randomly assigned to orthotopic pulmonary valve replacement using either decellularized (DECELL, n = 10) or ADSC-seeded valves (CELL, n = 9). Blood gas analysis was conducted intraoperatively and postoperatively to assess CPB-related metabolic changes. The follow-up period after surgery was 6 months. Key demographic and operative parameters were recorded, and early and late postoperative complications were monitored. Results No significant differences were observed in operative parameters or postoperative complications between the DECELL and CELL groups. Adult sheep exhibited longer anesthesia, CPB, and operative times due to tissue fragility but demonstrated better long-term survival than juveniles, who experienced more late-stage complications, including endocarditis. CPB exposure increased lactate and reduced hemoglobin levels, partic

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

How we grade evidence
AnimalsSheepPulmonary ValveTissue EngineeringHeart Valve ProsthesisHeart Valve Prosthesis ImplantationTreatment OutcomeFemale

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