Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis. (CELOPHIN)
Primary Purpose
Chronic Conjunctivitis, Stevens-Johnson Syndrome, Lyell Syndrome
Status
Active
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Single Dose
Double Dose
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Men and women over 18 years of age.
- Diagnosis of ocular pemphigoid in Foster stages I-IIcIIIb (2) or diagnosis of recurrent chronic or episodic inflammation accompanied by cicatricial conjunctivitis of the mucous membranes with ocular involvement after the acute phase of Stevens-Johnson Syndrome or Lyell Syndrome with insufficient disease control or inaceptable toxicity or impossibility to administer usual care treatments (according to physician or patient criteria)
- In the case of women of childbearing age, who are willing to use an effective contraceptive method during the period of participation in the study
- Consent to participate and signature of the informed consent
Exclusion Criteria:
- Signs of active infection on the ocular surface.
- History of neoplasms in the last 5 years. except for epithelial basal or squamous cell carcinoma
- Allergy to local anesthetics
- Patients who have participated in another clinical trial with medication during the 90 days prior to signing the IC
- Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study.
- Congenital or acquired immunodeficiencies.
- Major surgery or serious trauma of the subject in the semester prior to signing the IC.
- Pregnant or lactating women.
- Impossibility or refusal to carry out the follow-up required in the study by the patient
Sites / Locations
- Instituto Oftalmológico Fernández - Vega
- Hospital Universitario de Cruces
- Hospital General La Mancha Centro
- Hospital La Arruzafa
- Hospital General Universitario Gregorio Marañon
- Hospital Universitario Fundación Jiménez Diaz
- Hospital Universitario La Paz
- Hospital Clínico Universitario de Valladolid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single dose Allogenic Adiposse derived mesenchimal stem cells
Double dose Allogenic Adiposse derived mesenchimal stem cells
Arm Description
Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells
Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells at day 0 and 12,5 million cells at day 14
Outcomes
Primary Outcome Measures
Percentage of complications
Percentage of complications related to anesthesia, administration of investigational medicinal product and postoperative period.
Secondary Outcome Measures
Signs improvement
Changes from baseline in scarring conjunctivitis rating scale
Symptom improvement
Changes from baseline in Ocular Surface Disease Index (OSDI) questionnaire (0-48). The lower the rate obtained in the score, better the outcome.
Visual acuity improvement
Changes from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) (0-1,2).
The higher the rate obtained in the score, better the outcome.
changes in quality of life
Changes from baseline using the specific National Eye Institute-Visual Function Questionnaire 25 (NEI-VFQ-25) (0-100). The value of 0 is the lowest and 100 the best possible
evolution of the conjunctival flora
variation in the number and type of microorganisms in the conjunctival exudates, performing cultures and PCR herpes viridae
Full Information
NCT ID
NCT05520086
First Posted
August 22, 2022
Last Updated
July 5, 2023
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Effice Servicios Para la Investigacion S.L.
1. Study Identification
Unique Protocol Identification Number
NCT05520086
Brief Title
Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis.
Acronym
CELOPHIN
Official Title
Phase IIa Multicenter Clinical Trial to Determine the Feasibility and Safety of the Use of Adipose-derived Mesenchymal Stem Cells (ASC) in the Treatment of Patients With Cicatricial Conjunctivitis Associated With Lyell's Syndrome, Stevens-Johnson Syndrome and Pemphigoid of the Mucous Membranes With Ocular Involvement.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Effice Servicios Para la Investigacion S.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A phase IIa, open label, non controlled clinical trial to assess the feasibility and safety of allogeneic adipose-derived mesenchymal stem cells (ASC) in the treatment of cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson's syndrome and mucous membrane pemphigoid with ocular involvement
Detailed Description
A multicentre, nationwide clinical trial will be performed. 20 patients fulfilling eligibility criteria will be included in two different dose level cohorts: the first 10 patients included will receive a single cell application and the remainder 10 will be administered 2 cell applications separated by 15 days.
The investigational drug consists of locally administered, expanded, allogeneic adipose-derived adult mesenchymal stem cells (ASCs), at a dose of 5 million cells per ml (0,5 ml to be infused per quadrant)
Study cronogram: recruitment is estimated to take 8 months, and follow-up period will be 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Conjunctivitis, Stevens-Johnson Syndrome, Lyell Syndrome, Pemphigoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
2 consecutive cohorts will be included in order of recruitment. the first 10 patients will receive 1 single dose and the second 10 patients will receive 2 doses separated by 15 days
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single dose Allogenic Adiposse derived mesenchimal stem cells
Arm Type
Experimental
Arm Description
Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells
Arm Title
Double dose Allogenic Adiposse derived mesenchimal stem cells
Arm Type
Experimental
Arm Description
Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells at day 0 and 12,5 million cells at day 14
Intervention Type
Drug
Intervention Name(s)
Single Dose
Intervention Description
Single Dose: Administration of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection.
Intervention Type
Drug
Intervention Name(s)
Double Dose
Intervention Description
Repetead Dose: Administration of 2 doses, separated by 14 days, of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection.
Primary Outcome Measure Information:
Title
Percentage of complications
Description
Percentage of complications related to anesthesia, administration of investigational medicinal product and postoperative period.
Time Frame
Through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
Signs improvement
Description
Changes from baseline in scarring conjunctivitis rating scale
Time Frame
At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Title
Symptom improvement
Description
Changes from baseline in Ocular Surface Disease Index (OSDI) questionnaire (0-48). The lower the rate obtained in the score, better the outcome.
Time Frame
At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Title
Visual acuity improvement
Description
Changes from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) (0-1,2).
The higher the rate obtained in the score, better the outcome.
Time Frame
At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Title
changes in quality of life
Description
Changes from baseline using the specific National Eye Institute-Visual Function Questionnaire 25 (NEI-VFQ-25) (0-100). The value of 0 is the lowest and 100 the best possible
Time Frame
At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Title
evolution of the conjunctival flora
Description
variation in the number and type of microorganisms in the conjunctival exudates, performing cultures and PCR herpes viridae
Time Frame
At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women over 18 years of age.
Diagnosis of ocular pemphigoid in Foster stages I-IIcIIIb (2) or diagnosis of recurrent chronic or episodic inflammation accompanied by cicatricial conjunctivitis of the mucous membranes with ocular involvement after the acute phase of Stevens-Johnson Syndrome or Lyell Syndrome with insufficient disease control or inaceptable toxicity or impossibility to administer usual care treatments (according to physician or patient criteria)
In the case of women of childbearing age, who are willing to use an effective contraceptive method during the period of participation in the study
Consent to participate and signature of the informed consent
Exclusion Criteria:
Signs of active infection on the ocular surface.
History of neoplasms in the last 5 years. except for epithelial basal or squamous cell carcinoma
Allergy to local anesthetics
Patients who have participated in another clinical trial with medication during the 90 days prior to signing the IC
Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study.
Congenital or acquired immunodeficiencies.
Major surgery or serious trauma of the subject in the semester prior to signing the IC.
Pregnant or lactating women.
Impossibility or refusal to carry out the follow-up required in the study by the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolás Alejandre Alba
Organizational Affiliation
Hospital Fundación Jiménez Diaz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Oftalmológico Fernández - Vega
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33012
Country
Spain
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital General La Mancha Centro
City
Alcázar De San Juan
State/Province
Ciudad Real
ZIP/Postal Code
13600
Country
Spain
Facility Name
Hospital La Arruzafa
City
Córdoba
ZIP/Postal Code
14012
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis.
We'll reach out to this number within 24 hrs