Chronic ConjunctivitisPhase 1/2CELOPHINNCT05520086
Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis.
A Phase 1/2 study testing Single Dose and Double Dose in people with Chronic Conjunctivitis and Stevens-Johnson Syndrome, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 8 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Conjunctivitis, Stevens-Johnson Syndrome, Lyell Syndrome
- What is being tested?
- Single Dose and Double Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesSpain
- Study dates
- 11 Nov 2022to 11 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital General La Mancha Centro
Alcázar de San Juan, Ciudad Real, 13600
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital La Arruzafa
Córdoba, 14012
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario Fundación Jiménez Diaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Instituto Oftalmológico Fernández - Vega
Oviedo, Principality of Asturias, 33012
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
About this study
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.
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
Read the 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.
- Being tested
- Single Dose, Double Dose
- Medical subject headings
- Stevens-Johnson Syndrome, Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single DoseDrug
Single Dose: Administration of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection.
Double DoseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single dose Allogenic Adiposse derived mesenchimal stem cells | Experimental | Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells Receives: Drug: Single Dose |
| Double dose Allogenic Adiposse derived mesenchimal stem cells | Experimental | Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells at day 0 and 12,5 million cells at day 14 Receives: Drug: Double Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of complications
Percentage of complications related to anesthesia, administration of investigational medicinal product and postoperative period.
Measured: Through study completion, an average of 3 years
Secondary outcomes (5)
Signs improvement
Changes from baseline in scarring conjunctivitis rating scale
Measured: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
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.
Measured: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
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.
Measured: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
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
Measured: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
evolution of the conjunctival flora
variation in the number and type of microorganisms in the conjunctival exudates, performing cultures and PCR herpes viridae
Measured: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start11 Nov 2022
- Primary completion11 Jun 2024
- Study completion11 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
- Investigators
- Nicolás Alejandre Alba, Principal investigator, Hospital Fundación Jiménez Diaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520086
- Sponsor's protocol ID
- CELOPHIN
- Acronym
- CELOPHIN
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05520086
- Acronym / sponsor ID
- CELOPHIN / CELOPHIN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Nov 2024 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Single dose Allogenic Adiposse derived mesenchimal stem cells | Experimental | Drug: Single DoseAllogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells |
| Double dose Allogenic Adiposse derived mesenchimal stem cells | Experimental | Drug: Double DoseAllogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells at day 0 and 12,5 million cells at day 14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single DoseSingle Dose: Administration of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection. | Drug | Single dose Allogenic Adiposse derived mesenchimal stem cells |
| Double DoseRepetead 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. | Drug | Double dose Allogenic Adiposse derived mesenchimal stem cells |
Primary outcome
Percentage of complications
Time frame: Through study completion, an average of 3 years
Percentage of complications related to anesthesia, administration of investigational medicinal product and postoperative period.
5 secondary outcomes
Signs improvement
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Symptom improvement
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Visual acuity improvement
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
changes in quality of life
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
evolution of the conjunctival flora
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolás Alejandre Alba principal investigator
Hospital Fundación Jiménez Diaz
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Single Dose and Double Dose in people with Chronic Conjunctivitis and Stevens-Johnson Syndrome, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of complications (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.