Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery (IQF-BMA)
Systemic Biochemical Signature in Adults Undergoing Foot or Ankle Surgery: Integrating Routine Laboratory Markers to Assess the Functional Quality of Calcaneal Bone Marrow Aspirate Mesenchymal Stem Cells in a Prospective Cohort
This observational prospective cohort study will evaluate whether routine blood tests are associated with the functional quality of calcaneal bone marrow aspirate mesenchymal stem cells in adults undergoing clinically indicated foot or ankle surgery at a university hospital in Brazil. Participants aged 40 to 80 years, with or without comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers, will be eligible for inclusion.
Before surgery, participants will undergo routine blood tests, including complete blood count, glucose and lipid profile, mineral-renal markers, and tissue damage markers. During the clinically indicated surgery, calcaneal bone marrow aspirate will be collected from the same operative field. Mesenchymal stem cells will be isolated and evaluated in the laboratory for clonogenic capacity, osteogenic and adipogenic differentiation, cellular senescence, and secretion of inflammatory and anti-inflammatory cytokines.
A composite Functional Quality Index of Bone Marrow Aspirate (IQF-BMA) will be constructed from routine laboratory markers to characterize inflammatory, metabolic, mineral-renal, and tissue-damage burden. The primary objective is to examine the association between the IQF-BMA and mesenchymal stem cell functional outcomes, particularly clonogenic capacity. This exploratory study will not be used to guide individual treatment decisions.
調査の概要
状態
詳細な説明
This is a single-center, observational, prospective cohort study conducted at a university hospital in Brazil. The study will enroll 40 adults aged 40 to 80 years who are undergoing clinically indicated foot or ankle surgery. Participants may present with or without comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers. These clinical characteristics will be recorded as observational variables and will not define intervention assignments or separate study arms. All participants will provide written informed consent before any study procedures.
Before surgery, participants will undergo a panel of routine laboratory tests covering four domains: inflammatory burden, including complete blood count, derived inflammatory indices, and albumin; glycometabolic burden, including fasting glucose, oral glucose tolerance test when clinically feasible, HbA1c, triglycerides, and cholesterol profile; mineral-renal burden, including creatinine, urea, ionized calcium, phosphorus, magnesium, alkaline phosphatase, parathyroid hormone, and 25-OH vitamin D; and tissue-energetic damage, including lactate dehydrogenase, AST, and ALT.
During the clinically indicated orthopedic surgery, calcaneal bone marrow aspirate will be collected from the same operative field. Mesenchymal stem cells will be isolated, cultured, and evaluated using standardized functional assays, including clonogenic capacity, osteogenic differentiation, adipogenic differentiation, cellular senescence, cytokine secretion, and cellular viability.
The Functional Quality Index of Bone Marrow Aspirate (IQF-BMA) will be constructed from standardized routine laboratory variables representing inflammatory, glycometabolic, mineral-renal, and tissue-energetic domains. The primary analysis will examine the association between the IQF-BMA and the clonogenic capacity of calcaneal bone marrow mesenchymal stem cells. Secondary analyses will examine associations between laboratory markers or the composite index and other cellular functional outcomes. Results will be reported primarily as effect estimates and 95% confidence intervals to support the planning of future, larger studies.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Leonardo H Dalcheco Messias, PhD
- 電話番号：+5519998118989
- メール：leonardo.messias@usf.edu.br
研究連絡先のバックアップ
- 名前：Leonardo H Dalcheco Messias, PhD
- 電話番号：19998118989
- メール：leonardo.messias@usf.edu.br
研究場所
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São Paulo
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Bragança Paulista、São Paulo、ブラジル、12916900
- Leonardo H Dalcheco Messias
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コンタクト：
- Leonardo Dalcheco Messias
- 電話番号：19998118989
- メール：leonardo.messias@usf.edu.br
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria
- Age 40 to 80 years.
- Scheduled for clinically indicated foot or ankle surgery at the participating university hospital.
- Ability to understand the study procedures and provide written informed consent.
- Willingness to provide preoperative blood samples and intraoperative calcaneal bone marrow aspirate according to the study protocol.
- Participants may have comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers. These clinical characteristics will be recorded for observational analyses and do not define separate study groups.
Exclusion Criteria
- Critical limb ischemia without revascularization options or hemodynamic instability.
- Active systemic infection or sepsis at the time of enrollment.
- End-stage renal disease requiring dialysis.
- Current use of high-dose systemic corticosteroids or other immunosuppressive drugs.
- Current or recent malignancy within the last 5 years, except adequately treated non-melanoma skin cancer.
- Significant cognitive impairment or psychiatric condition that, in the opinion of the investigator, precludes informed consent or adherence to study procedures.
- Pregnancy or breastfeeding.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Foot/Ankle Surgery Cohort
Adults undergoing clinically indicated foot or ankle surgery at a university hospital in Brazil, with or without comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers.
Blood samples and calcaneal bone marrow aspirate will be collected for systemic laboratory tests and mesenchymal stem cell functional assays.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clonogenic capacity of calcaneal bone marrow mesenchymal stem cells (CFU-F)
時間枠：Up to 14 days after bone marrow aspirate collection.
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Number of colony-forming unit fibroblasts (CFU-F) per milliliter of calcaneal bone marrow aspirate, quantified in primary culture under standardized conditions.
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Up to 14 days after bone marrow aspirate collection.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Osteogenic and adipogenic differentiation of mesenchymal stem cells
時間枠：Up to 28 days after bone marrow aspirate collection.
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Osteogenic and adipogenic differentiation capacity of calcaneal bone marrow mesenchymal stem cells, assessed by alkaline phosphatase activity and semi-quantitative scoring of Alizarin Red and Oil Red O staining.
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Up to 28 days after bone marrow aspirate collection.
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協力者と研究者
捜査官
- 主任研究者：Vanessa Bertolucci, PhD Candidate、Universidade Sao Francisco
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- USF-IQF-BMA-DFU-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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