Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)
Autologous AD-MSC Transplantation in Peritoneal Dialysis Patients With Ultra Filtration Failure and Evaluation of Cellular and Molecular Effects of Mesenchymal Stem Cell Infusion on Peritoneal Fibrosis
Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS). Using the potential features of MSCs in the treatment of fibrosis may offer new insights into reconstruction the damaged tissues. The project intends to transplant autologous MSCs to ten peritoneal dialysis patients with ultra-filtration failure. It's going to study infusion effects in clinical, cellular and molecular levels.
So in this trial, we will evaluate the effects of this intervention after intravenous injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as the control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months after first injection.
調査の概要
詳細な説明
Chronic kidney disease is defined as a reduced glomerular filtration rate, increased urinary albumin excretion, or both, and is an increasing public health issue. Prevalence is estimated to be 8-16% worldwide. Stage 5 CKD is often called end-stage kidney disease and usually means that the patient requires renal replacement therapy (RRT), which may involve a kidney transplant or a form of dialysis. One of the options in RRT is continuous ambulatory peritoneal dialysis (CAPD). CAPD is characterized by a continuous removal of extracellular fluid by peritoneal membrane. It should be noted that like any other peritoneal dialysis therapy, CAPD has Short or long-term complications and UFF is the most common functional disorder in which the peritoneal ultrafiltration membrane damaged.
This project intends to evaluate, the role of autologous mesenchymal stem cells in improvement of peritoneal membrane function in peritoneal dialysis patients who have ultrafiltration failure up to 6 months.
In this study, 10 male and female subjects who are on peritoneal dialysis for at least two years and have ultrafiltration failure with age range of 18 to 70 years will be enrolled. Patients will be selected from peritoneal dialysis patients attending the peritoneal dialysis ward of Dr. Shariati hospital. The main inclusion criteria is to be on peritoneal dialysis for at least last two years and having Ultrafiltration failure. After obtaining the consent form, a sample of fat tissue will be obtained by a general surgeon under sterilized condition from patients and then in the specialized lab, the mesenchymal stem cells will be separated and cultured to reach appropriate numbers (106/kg). The cells will be injected through peripheral vein in hospital setting. Patients will be followed-up (clinically and laboratory) at baseline and at week 3, week 6, month 3, month 4 and month 6. The clinical assessment and peritoneal function tests will be performed in each visit. Outcome measures: The main outcome measures that periodically will be assessed include: D/P cr, D/P urea, D0/D glucose, PET, KT/V urea, Glomerular filtration rate (GFR)
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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-
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Tehran、イラン・イスラム共和国
- Royan Institute
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- peritoneal dialysis for at least last two years and
- Ultrafiltration failure
- Both genders
- Age 18-70 years
- inform consent signing
Exclusion Criteria:
- Inability of patients to attend visits and regular testing
- Estimated lifetime less than one year
- Use of immunosuppressive drugs
- Pregnancy
- Malignancy
- Coagulative disorders
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：AD-MSC
The patients with ultra filtration failure (UFF) underwent AD-MSC injection.
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Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
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プラセボコンパレーター：Placebo
The patients with ultra filtration failure (UFF) underwent Placebo injection.
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Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
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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 |
|---|---|---|
|
Systemic infection
時間枠：6months
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Evaluation the rate of systemic infection in patients with UFF after cell therapy.
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6months
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Hepatic failure
時間枠：6 months
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Evaluation the rate of hepatic failure in patients with UFF after cell therapy.
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6 months
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Renal failure
時間枠：6 months
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Evaluation the rate of renal failure in patients with UFF after cell therapy.
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6 months
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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 |
|---|---|---|
|
Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).
時間枠：6 months
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Evaluation the change of (D/P Cr) in patients with UFF after cell therapy.
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6 months
|
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Ratio of 4-hour dialysate/plasma urea (D/P urea )
時間枠：6 months
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Evaluation the change of D/P in patients with UFF after cell therapy.
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6 months
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Ratio of dialysate glucose concentrations (D/D glucose )
時間枠：6 months
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Evaluation the change of D/D glucose in patients with UFF after cell therapy.
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6 months
|
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peritoneal membrane transport function
時間枠：6 months
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Assessment of peritoneal membrane transport function by peritoneal equilibration test (PET)
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6 months
|
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Glomerular filtration rate (GFR):
時間枠：6 months
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Evaluation the change of Glomerular filtration rate (GFR) in patients with UFF after cell therapy.
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6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Soroosh Shekarchian, MD、Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
- スタディディレクター：Nasser Aghdami, MD,PhD、Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
- スタディディレクター：Gholamreza Pourmand, MD、Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
- スタディディレクター：Iraj Najafi, MD、Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
- 主任研究者：Sudabeh Alatab, MD、Sudabeh
- 主任研究者：Reza Moghadasali, PhD、Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
その他の研究ID番号
- Royan-kidney-006
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?
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