NCT03878628

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Oct 2019

Typical duration for early_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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

March 12, 2019

Last Update Submit

November 15, 2023

Conditions

Dry EyeKerato Conjunctivitis SiccaAqueous Tear Deficiency

Outcome Measures

Primary Outcomes (8)

  • Pain at injection site: grade

    grade 1: mild pain, grade 2: moderate pain, grade 3: severe pain

    4 months after treatment

  • Infection at injection site

    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.

    4 months after treatment

  • Bleeding at injection site

    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 months after treatment

  • Eyelid function disorder

    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.

    4 months after treatment

  • Periorbital edema

    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.

    4 months after treatment

  • Ocular discomfort

    grade 1: mild discomfort, grade 2: moderate pain, grade 3: disabling pain.

    4 months after treatment

  • Flu-like symptoms

    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)

    4 months after treatment

  • Fever

    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

    4 months after treatment

Secondary Outcomes (5)

  • OSDI questionnaire

    4 months after treatment

  • Schirmer's I test

    4 months after treatment

  • Tear osmolarity

    4 months after treatment

  • Ocular SICCA Grading Score

    4 months after treatment

  • HLA anti-bodies

    4 months after treatment

Study Arms (1)

Adipose tissue-derived mesenchymal stem cells

EXPERIMENTAL

Approximately 11 million ASCs in a 0.5 ml suspension

Drug: Adipose tissue-derived mesenchymal stem cells

Interventions

Adipose tissue-derived mesenchymal stem cellsDRUG

CSCC\_ASC(22), a ready-to-use suspension containing 22 million adipose tissue-derived mesenchymal stem cells per millilitre

Adipose tissue-derived mesenchymal stem cells

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, DK, 2200, Denmark

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Steffen Heegaard, MD, DMSc

    Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 18, 2019

Study Start

October 16, 2019

Primary Completion

June 30, 2020

Study Completion

February 20, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)