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Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)

26. april 2017 opdateret af: Royan Institute

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. peritoneal dialysis for at least last two years and
  2. Ultrafiltration failure
  3. Both genders
  4. Age 18-70 years
  5. inform consent signing

Exclusion Criteria:

  1. Inability of patients to attend visits and regular testing
  2. Estimated lifetime less than one year
  3. Use of immunosuppressive drugs
  4. Pregnancy
  5. Malignancy
  6. Coagulative disorders

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AD-MSC
The patients with ultra filtration failure (UFF) underwent AD-MSC injection.
Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
Placebo komparator: Placebo
The patients with ultra filtration failure (UFF) underwent Placebo injection.
Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Systemic infection
Tidsramme: 6months
Evaluation the rate of systemic infection in patients with UFF after cell therapy.
6months
Hepatic failure
Tidsramme: 6 months
Evaluation the rate of hepatic failure in patients with UFF after cell therapy.
6 months
Renal failure
Tidsramme: 6 months
Evaluation the rate of renal failure in patients with UFF after cell therapy.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).
Tidsramme: 6 months
Evaluation the change of (D/P Cr) in patients with UFF after cell therapy.
6 months
Ratio of 4-hour dialysate/plasma urea (D/P urea )
Tidsramme: 6 months
Evaluation the change of D/P in patients with UFF after cell therapy.
6 months
Ratio of dialysate glucose concentrations (D/D glucose )
Tidsramme: 6 months
Evaluation the change of D/D glucose in patients with UFF after cell therapy.
6 months
peritoneal membrane transport function
Tidsramme: 6 months
Assessment of peritoneal membrane transport function by peritoneal equilibration test (PET)
6 months
Glomerular filtration rate (GFR):
Tidsramme: 6 months
Evaluation the change of Glomerular filtration rate (GFR) in patients with UFF after cell therapy.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Soroosh Shekarchian, MD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
  • Studieleder: 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.
  • Studieleder: Gholamreza Pourmand, MD, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
  • Studieleder: Iraj Najafi, MD, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
  • Ledende efterforsker: Sudabeh Alatab, MD, Sudabeh
  • Ledende efterforsker: Reza Moghadasali, PhD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2015

Primær færdiggørelse (Faktiske)

1. februar 2017

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

12. juni 2016

Først indsendt, der opfyldte QC-kriterier

12. juni 2016

Først opslået (Skøn)

16. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2017

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Royan-kidney-006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Ultra Filtration Failure

Kliniske forsøg med Intravenous injection

Abonner