NCT03665649

Brief Summary

The endometrium is a tissue with high capacity of renewal ("self-renewal"). This process is regulated by stem cells. Recent studies have shown that bone marrow-derived stem cells (BMDSCs) contribute to tissues and organs regeneration, including the murine and human endometrium. Additionally, BMDSCs have the ability to differentiate into functional endometrial and stromal epithelial cells. Asherman's Syndrome (AS) also referred to as intrauterine adhesions (AIU), is an acquired uterine condition characterized by the formation of adhesions inside the uterus. In many cases the front and back walls of the uterus stick to one another. Most patients with AS have menstrual abnormalities, pelvic pain, recurrent miscarriage, and infertility, and psychological disorders. Currently, hysteroscopy is considered the gold standard of methods for the diagnosis of intrauterine adhesions. However, it has a limited capacity for treatment, especially in moderate or severe cases in which permanent infertility can occur. For the first time, our investigation group demonstrated the possibility of regenerating endometrial tissue through bone marrow-derived stem cells (Santamaria et al., 2016). This project aims to determine the safety, tolerability and biodistribution of IGX1 (CD133+ cells selected after mobilization and collection of peripheral blood progenitor cells - CPSP) afte rthe intraarterial injection in rats with induced Asherman's Syndrome. Therefore, the focus of this project is to satisfy the preclinical requirements set out by the the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) in relation to the Phase I/II clinical trial "Phase I-II clinical trial of advanced, prospective, open, non-randomized, uncontrolled (before-after study), explanatory, multicentre cell therapy , national, intervention with a single treatment group in patients of reproductive age with gestational desire diagnosed with Asherman's Syndrome grade II, III or IV, treated by autologous non-expanded bone marrow stem/progenitor cells selected (IGX1)" (IGX1-ENT-XS-16-01)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

September 7, 2018

Last Update Submit

July 16, 2019

Conditions

Asherman Syndrome

Keywords

Asherman SyndromeBone marrow-derived stem cellsEndometrial regenerationAssisted reproduction techniquesEndometrial physiopathologyCD133+Endometrial atrophyEndometrial thickness

Outcome Measures

Primary Outcomes (2)

  • Number of CD133+

    Total number of CD133+ obtained after the apheresis

    0 hours

  • Polymorphonuclear cells

    Total number of polymorphonuclear cells obtained

    0 hours

Secondary Outcomes (4)

  • Percentage of viable cells

    0 hours, 3 hours and 18 hours

  • Number of Colony-forming unit (CFU)

    0 hours, 3 hours and 18 hours

  • Concentration of Pathogens

    0 hours

  • Expression of hematopoietic stem cells (subtypes: CD133+, CD56+, CD66+, CD14+, CD19+, CD3+, CD45+, CD34+)

    18 hours from extraction

Study Arms (1)

CD133+ human donors

OTHER

CD133+ cells isolation

Procedure: CD133+ cells isolation

Interventions

CD133+ cells isolationPROCEDURE

Hematopoietic precursors from human donors will be mobilized by administering Colony Stimulating Factors (G-CSF) for 5 days (according to the clinical standard administration) and subsequently CD133+ cells will be isolated and transferred in a murine model.

CD133+ human donors

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Donors of of hematopoietic stem cells whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
  • Women of reproductive age between 18-44 years old (both inclusive).
  • BMI: 18-30 Kg/m2 (both inclusive)
  • Adequate hepatic and renal function defined as:
  • Total bilirubin \<1.5x Higher Normal Validity (VSN)
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \<2.5x VSN and
  • Serum creatinine \<1.0 mg/dl; if the serum creatinine is \>1.0 mg/dl, the estimated glomerular filtration rate (EGF) should be \>60 ml/min/1.73 m2.
  • Absence of severe cardiac pathology.
  • Negative blood pregnancy test.
  • Eastern Cooperative Oncology Group (ECOG) = 0-1.
  • Negative serology for HIV, HCV, HBSAg, HBcAg and Syphilis (recent \<30 days).
  • Normal coagulation study.
  • Adequate peripheral venous access.
  • Absence of serious psychiatric illness.
  • Ability of the donor to understand and comply with the study procedures.

You may not qualify if:

  • Absence of peripheral venous access.
  • Patients who have participated in another clinical trial or have received an investigational treatment during the last 30 days, unless the sponsor approves it.
  • Existence of serious or uncontrolled bacterial, fungal or viral infections that, could interfere with the participation of the donor in the study or in the evaluation of the results.
  • Any disease or unstable medical condition that may endanger the safety of the donor and their compliance with the study. (i.e., previous or current oncological or hematological diseases).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall D´Hebron

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

GynatresiaMacular Dystrophy, Retinal, 2

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Xavier Santamaria, MD PhD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Gomez, BSc MSc

CONTACT

+34 96 390 53 10carlos.gomez@igenomix.com

Xavier Santamaria, MD PhD

CONTACT

+34 93 206 30 00xavier.santamaria@igenomix.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 11, 2018

Study Start

July 27, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)