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

26. april 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert 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)

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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) .

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: 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.
  • Hovedetterforsker: Sudabeh Alatab, MD, Sudabeh
  • Hovedetterforsker: Reza Moghadasali, PhD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2015

Primær fullføring (Faktiske)

1. februar 2017

Studiet fullført (Faktiske)

1. mars 2017

Datoer for studieregistrering

Først innsendt

12. juni 2016

Først innsendt som oppfylte QC-kriteriene

12. juni 2016

Først lagt ut (Anslag)

16. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. april 2017

Sist bekreftet

1. desember 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Royan-kidney-006

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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