NCT01562002

Brief Summary

The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

March 22, 2012

Last Update Submit

January 7, 2015

Conditions

Limbus Corneae Insufficiency Syndrome

Keywords

limbuscorneainsufficiency syndromestem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Viability and safety of mesenchymal stem cell transplant

    Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy

    1 Year

Secondary Outcomes (2)

  • Absence of complications in pre and peri surgical implantation

    1 Week

  • Improvement of 2 lines in Best Corrected Visual Acuity

    12 month

Study Arms (2)

Bone Marrow mesenchymal stem cell

EXPERIMENTAL

Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant

Procedure: Stem Cell with Amniotic Membrane Transplant

Allogenic limbal stem cell Transplant

ACTIVE COMPARATOR

Stem Cell with Amniotic Membrane Transplant

Procedure: Stem Cell with Amniotic Membrane Transplant

Interventions

Stem Cell with Amniotic Membrane TransplantPROCEDURE

Single stem cell expansion in amniotic membrane transplant

Allogenic limbal stem cell TransplantBone Marrow mesenchymal stem cell

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female older than 18 years.
  • Signed Informed consent
  • Compromise of contraceptive method during all trial for any potential childbearing female.
  • Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology.
  • Availability for all the scheduled visits during the study

You may not qualify if:

  • Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis.
  • Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available.
  • No availability for all scheduled visits during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IOBA

Valladolid, Valladolid, 47011, Spain

Location

Related Publications (2)

  • Perez I, Galindo S, Lopez-Miguel A, Nieto-Miguel T, de la Mata A, Lopez-Paniagua M, Alberca M, Herreras JM, Calonge M. In Vivo Confocal Microscopy in Limbal Stem Cell Deficiency After Mesenchymal Stem Cell Transplantation: A Sub-analysis from a Phase I-II Clinical Trial. Ophthalmol Ther. 2023 Dec;12(6):3251-3262. doi: 10.1007/s40123-023-00809-7. Epub 2023 Sep 29.

    PMID: 37773479DERIVED

  • Calonge M, Perez I, Galindo S, Nieto-Miguel T, Lopez-Paniagua M, Fernandez I, Alberca M, Garcia-Sancho J, Sanchez A, Herreras JM. A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency. Transl Res. 2019 Apr;206:18-40. doi: 10.1016/j.trsl.2018.11.003. Epub 2018 Nov 22.

    PMID: 30578758DERIVED

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Margarita Calonge, MD, PhD

    Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 23, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

ES(1)