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

NCT02801890 | Completed Phase 1 DMC

• 1 other identifier: Royan-kidney-006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultra Filtration Failure

Outcome Measures

Primary Outcomes (3)

• Systemic infection

  Evaluation the rate of systemic infection in patients with UFF after cell therapy.

  6months

• Hepatic failure

  Evaluation the rate of hepatic failure in patients with UFF after cell therapy.

  6 months

• Renal failure

  Evaluation the rate of renal failure in patients with UFF after cell therapy.

  6 months

Secondary Outcomes (5)

• Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).

  6 months

• Ratio of 4-hour dialysate/plasma urea (D/P urea )

  6 months

• Ratio of dialysate glucose concentrations (D/D glucose )

  6 months

• peritoneal membrane transport function

  6 months

• Glomerular filtration rate (GFR):

  6 months

Study Arms (2)

AD-MSC

EXPERIMENTAL

The patients with ultra filtration failure (UFF) underwent AD-MSC injection.

Biological: Intravenous injection

Placebo

PLACEBO COMPARATOR

The patients with ultra filtration failure (UFF) underwent Placebo injection.

Biological: Intravenous injection

Interventions

Intravenous injection BIOLOGICAL

Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .

AD-MSC; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• peritoneal dialysis for at least last two years and
• Ultrafiltration failure
• Both genders
• Age 18-70 years
• inform consent signing

You may not qualify if:

• Inability of patients to attend visits and regular testing
• Estimated lifetime less than one year
• Use of immunosuppressive drugs
• Pregnancy
• Malignancy
• Coagulative disorders

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

MeSH Terms

Interventions

Injections, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• 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.

  STUDY DIRECTOR

• Gholamreza Pourmand, MD

  Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.

  STUDY DIRECTOR

• Iraj Najafi, MD

  Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.

  STUDY DIRECTOR

• Sudabeh Alatab, MD

  Sudabeh

  PRINCIPAL INVESTIGATOR

• Soroosh Shekarchian, MD

  Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

• Reza Moghadasali, PhD

  Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 16, 2016
• Study Start: August 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 27, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)