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Treatment With Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Aqueous Deficient Dry Eye Disease (MESADDE)

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ClinicalTrials.gov Identifier: NCT03878628
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Møller-Hansen, Rigshospitalet, Denmark

Brief Summary:
The objective of this study is to assess the safety and feasibility of allogeneic adipose tissue-derived mesenchymal stem cells (ASCs) injected into the lacrimal gland in a smaller groups of 7 patients with Aqueous Deficient Dry Eye Disease (ADDE)

Condition or disease Intervention/treatment Phase
Dry Eye Kerato Conjunctivitis Sicca Aqueous Tear Deficiency Drug: Adipose tissue-derived mesenchymal stem cells Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment With Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Aqueous Deficient Dry Eye Disease
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Adipose tissue-derived mesenchymal stem cells
Approximately 11 million ASCs in a 0.5 ml suspension
Drug: Adipose tissue-derived mesenchymal stem cells
CSCC_ASC(22), a ready-to-use suspension containing 22 million adipose tissue-derived mesenchymal stem cells per millilitre




Primary Outcome Measures :
  1. Pain at injection site: grade [ Time Frame: 4 months after treatment ]
    grade 1: mild pain, grade 2: moderate pain, grade 3: severe pain

  2. Infection at injection site [ Time Frame: 4 months after treatment ]
    grade 1: localized; local intervention indicated, grade 2: oral intervention indicated (antibiotic, antifungal, antiviral), grade 3: intravenously administered (IV) antibiotic, antifungal, or antiviral agent indicated; or operative intervention indicated, grade 4: life-threatening consequences; urgent intervention needed.

  3. Bleeding at injection site [ Time Frame: 4 months after treatment ]
    Grade 1: Mild bleeding; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization indicated.

  4. Eyelid function disorder [ Time Frame: 4 months after treatment ]

    Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated;

    Grade 2: Symptomatic; nonoperative intervention indicated; limiting instrumental ADL;

    Grade 3: Limiting self care ADL; operative intervention indicated.


  5. Periorbital edema [ Time Frame: 4 months after treatment ]

    Grade 1: Soft or non-pitting;

    Grade 2: Indurated or pitting edema; topical intervention indicated;

    Grade 3: Edema associated with visual disturbance; increased intraocular pressure, glaucoma or retinal hemorrhage; optic neuritis; diuretics indicated; operative intervention indicated.


  6. Ocular discomfort [ Time Frame: 4 months after treatment ]

    grade 1: mild discomfort,

    grade 2: moderate pain,

    grade 3: disabling pain.


  7. Flu-like symptoms [ Time Frame: 4 months after treatment ]

    grade 1: Mild flu-like symptoms present;

    grade 2: Moderate flu-like symptoms, limiting self care ADL;

    grade 3: Severe flu-like symptoms, limiting self care ADL)


  8. Fever [ Time Frame: 4 months after treatment ]
    grade 1: 38,0-39,0 Cº; grade 2: >39,0-40,0 Cº; grade 3: >40,0 Cº for ≤ 24 hours; grade 4: >40,0 Cº for > 24 hours


Secondary Outcome Measures :
  1. OSDI questionnaire [ Time Frame: 4 months after treatment ]
    Change in severity of dry eye symptoms as assessed with the OSDI questionnaire with a score of 0-100, where 0 is "no symptoms" and 100 is "severe symptoms"

  2. Schirmer's I test [ Time Frame: 4 months after treatment ]
    Change in tear production as evaluated with the Schirmer's I test

  3. Tear osmolarity [ Time Frame: 4 months after treatment ]
    Change in tear osmolarity measured with TearLab(TM)

  4. Ocular SICCA Grading Score [ Time Frame: 4 months after treatment ]
    Change in objective signs of DED as evaluated with the Ocular SICCA Grading Score from 0-12 where 0 is "no staining of the ocular surface" and 12 is "severe staining of the ocular surface"

  5. HLA anti-bodies [ Time Frame: 4 months after treatment ]
    Development of anti-HLA anti-bodies evaluated with Luminex HLA anti-body screening



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OSDI-score > 30
  • Schirmer's test 2-5 mm in 5 minutes
  • TBUT < 10 sec.

Exclusion Criteria:

  • Previously established allergies to Oxybuprocaine or DMSO (rare)
  • Reduced immune response (e.g. HIV positive)
  • Pregnancy or planned pregnancy within the next 2 years
  • Breastfeeding
  • Treatment with an anticoagulant that cannot be stopped during the intervention period
  • Treatment with systemic medication known to reduce tear production (with an odds ratio >2,0 (3)): anxiolytics, antipsychotics, and inhaled steroids.
  • Topical treatment with eye drops other than lubricants
  • Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878628


Contacts
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Contact: Michael Møller-Hansen, MD +4528738771 moller.hansen@gmail.com

Locations
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Denmark
Rigshospitalet Not yet recruiting
Copenhagen, DK, Denmark, 2200
Contact: Michael Møller-Hansen, MD    28738771    moller.hansen@gmail.com   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Chair: Steffen Heegaard, MD, DMSc Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen

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Responsible Party: Michael Møller-Hansen, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03878628     History of Changes
Other Study ID Numbers: 001-2018
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctivitis
Keratoconjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases