GVHDPhase 2NCT07014059
Autologous Serum Obtained by a Closed-Circuit Collection Device
A Phase 2 study testing Autologous Serum 20% in people with GVHD and Meibomian Gland Dysfunction (Disorder), run by GIANCARLO FATOBENE at 1 site in Brazil.
Trial summary
Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GVHD, Meibomian Gland Dysfunction (Disorder), Stevens-Johnson Syndrome
- What is being tested?
- Autologous Serum 20%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jun 2025to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- ≥ 18 years
- Dry eye and/or chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;
- Peripheral venous access or PICC that allows the collection of whole blood.
Who cannot join
- Active ocular infection;
- Hemoglobin < 11 g/dL;
- Angina, MI, or stroke in the last 30 days;
- Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;
- Active ocular or systemic infection at the time of collection;
- Inability to attend follow-up visits at 6 and 12 weeks;
Show all 10Show fewer
- Active hematological malignancy (except measurable residual disease) or solid malignancy (except non-melanoma skin cancer);
- Positive for HIV, HCV, HBV, HTLV, Chagas disease, or syphilis;
- Life expectancy < 6 months;
- Not pregnant (as reported by the participant).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "In Vivo Evaluation of Topical Ocular Use of Autologous Serum Obtained by a Closed-Circuit Collection Device."
Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.
Read the detailed description
Autologous Serum exhibits characteristics very similar to those of tears, such as pH, osmolarity, vitamins, and Immunoglobulin A. It also contains growth factors, nutritional factors, and antibacterial components that are necessary for the maintenance of cellular viability in the epithelial repair process. The use of autologous serum eye drops was first described in 1984 by Fox et al., in research for a preservative-free tear substitute. Subsequently, in 1999, Tsubota et al. found that, due to the presence of growth factors and vitamins, autologous serum could have a true epithelial trophic potential for the ocular surface. The autologous serum eye drops are not only a lubricant for the ocular surface but also provide various essential substances for the reconstruction of epithelial damage, including vitamin A, epithelial growth factor, fibronectin, and a variety of cytokines. With these epithelial trophic factors, autologous serum facilitates proliferation, migration, and differentiation of the ocular surface epithelium. Moreover, it is known for its anti-catabolic properties, inhibiting the inflammatory cascade triggered by interleukin-1, which prevents tissue destruction. Therefore, autologous serum eye drops have been effective in the treatment of persistent epithelial defects, neurotrophic ulcers, superior limbic keratoconjunctivitis, dry eye conditions, graft-versus-host disease (GVHD), or after refractive surgeries, such as LASIK (Laser Assisted In Situ Keratomileusis). In 2020, Wang et al. published an article with 7 randomized controlled trials comparing the use of autologous serum versus artificial tears in patients with dry eye syndrome. In the meta-analysis, all 7 studies evaluated subjective symptoms and showed that autologous serum eye drops were superior to ocular lubricants in alleviating and remitting symptoms. It was shown that autologous serum eye drops significantly improved parameters such as OSDI (Ocular Surface Disease Index), tear break-up time, and Bengal Rose staining when compared to the control group using ocular lubricants. Given the numerous properties of autologous serum eye drops, there is no doubt about their benefit and effectiveness in treating several ocular surface diseases, including ocular GVHD. However, the difficulty in accessing production and the substantial cost of autologous serum eye drops are the main challenges, and their use is often limited to more severe dry eye cases and those refractory to conventional treatment.
- Conditions
- GVHD, Meibomian Gland Dysfunction (Disorder), Stevens-Johnson Syndrome, Limbal Keratoconjunctivitis, Recurrent Erosions of Persistent Epithelial Defects, Neurotrophic Ulcer
- Being tested
- Autologous Serum 20%
- Keywords
- soro autologo, gvhd, Sjogren&#39;s Syndrome (SS), Meibomian Gland Dysfunction (Disorder), Stevens-Johnson Syndrome, Limbal Keratoconjunctivitis, Neurotrophic Ulcer, Recurrent Erosions of Persistent Epithelial Defects, Study Protocol - Autologous Serum, Autologous Serum
- Medical subject headings
- Meibomian Gland Dysfunction, Stevens-Johnson Syndrome, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Serum 20%Drug
The collection of autologous serum in a closed blood processing system for ocular use
| Study group | Role | What they receive |
|---|---|---|
| Production of autologous serum in a closed system for ocular use | Experimental | Not described Receives: Drug: Autologous Serum 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using the collection device under testing
Proportion of blood collections that resulted in successful production of final autologous serum containers suitable for patient use.
Measured: 2 years
Secondary outcomes (18)
Median pre-freezing number of leukocytes in autologous serum
0.0-0.03x10ˆ3/mcL;
Measured: 2 years
Median pre-freezing number of red blood cells in autologous serum
0.0-0.03x10ˆ6/mcL;
Measured: 2 years
Median pre-freezing number of platelets in autologous serum
0.0-0.03x10ˆ3/mcL;
Measured: 2 years
Median pre and post-freezing pH in autologous serum
7.00-7.50;
Measured: 2 years
Pre-freezing microbiological test of autologous serum
Positive or negative;
Measured: 2 years
NIH ocular score
0-3
Measured: baseline, 6 weeks, 12 weeks, and end of treatment
Ocular Surface Disease Index
Reported by the patient from 0 to 100
Measured: Baseline, 6 weeks, 12 weeks, and end of treatment
Global ocular symptom score
Reported by the patient from 0 to 10
Measured: Baseline, 6 weeks, 12 weeks, and end of treatment
Lee score ocular subscale
Reported by the patient from 0 to 100
Measured: Baseline, 6 weeks, 12 weeks, and end of treatment
Corneal staining score (fluorescein)
Bijsterveld scale: 0-9.
Measured: Baseline, 6 weeks, 12 weeks
Corneal staining score (Rose Bengal)
Bijsterveld scale: 0-9.
Measured: Baseline, 6 weeks, 12 weeks
Meibography
Good, moderate, poor
Measured: Baseline, 6 weeks, 12 weeks
Schirmer test
0-30 mm in 5 minutes
Measured: Baseline, 6 weeks, 12 weeks
Non-invasive tear film break-up
0-50 seconds
Measured: Baseline, 6 weeks, 12 weeks
Tear film lipid layer
0-3
Measured: Baseline, 6 weeks, 12 weeks
Adherence to the use of autologous serum
Percentage of doses administered vs. planned doses: 0-100%
Measured: At 6 and 12 weeks post-treatment
Patient's qualitative evaluation of the use of autologous serum
Qualitative questionnaire
Measured: At 12 weeks post-treatment
Team's qualitative perception of the feasibility of collection and production of autologous serum
Qualitative questionnaire
Measured: At 50% of planned recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start20 Jun 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GIANCARLO FATOBENE
- Sponsor type
- University, hospital or other
- Collaborators
- JP Farma
- Responsible party
- Sponsor-investigator, GIANCARLO FATOBENE, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014059
- Sponsor's protocol ID
- 78127624.4.0000.0068
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "In Vivo Evaluation of Topical Ocular Use of Autologous Serum Obtained by a Closed-Circuit Collection Device."
- ClinicalTrials.gov ID
- NCT07014059
- Acronym / sponsor ID
- 78127624.4.0000.0068
- Conditions
- GVHD, Meibomian Gland Dysfunction (Disorder), Stevens-Johnson Syndrome, Limbal Keratoconjunctivitis, Recurrent Erosions of Persistent Epithelial Defects, Neurotrophic Ulcer
- Keywords
- soro autologo, gvhd, Sjogren&#39;s Syndrome (SS), Meibomian Gland Dysfunction (Disorder), Stevens-Johnson Syndrome, Limbal Keratoconjunctivitis, Neurotrophic Ulcer, Recurrent Erosions of Persistent Epithelial Defects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- GIANCARLO FATOBENEUniversity, hospital or other
- Collaborators
- JP Farma
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Jun 2025 (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.
Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.
Detailed description
Autologous Serum exhibits characteristics very similar to those of tears, such as pH, osmolarity, vitamins, and Immunoglobulin A. It also contains growth factors, nutritional factors, and antibacterial components that are necessary for the maintenance of cellular viability in the epithelial repair process. The use of autologous serum eye drops was first described in 1984 by Fox et al., in research for a preservative-free tear substitute. Subsequently, in 1999, Tsubota et al. found that, due to the presence of growth factors and vitamins, autologous serum could have a true epithelial trophic potential for the ocular surface. The autologous serum eye drops are not only a lubricant for the ocular surface but also provide various essential substances for the reconstruction of epithelial damage, including vitamin A, epithelial growth factor, fibronectin, and a variety of cytokines. With these epithelial trophic factors, autologous serum facilitates proliferation, migration, and differentiation of the ocular surface epithelium. Moreover, it is known for its anti-catabolic properties, inhibiting the inflammatory cascade triggered by interleukin-1, which prevents tissue destruction. Therefore, autologous serum eye drops have been effective in the treatment of persistent epithelial defects, neurotrophic ulcers, superior limbic keratoconjunctivitis, dry eye conditions, graft-versus-host disease (GVHD), or after refractive surgeries, such as LASIK (Laser Assisted In Situ Keratomileusis). In 2020, Wang et al. published an article with 7 randomized controlled trials comparing the use of autologous serum versus artificial tears in patients with dry eye syndrome. In the meta-analysis, all 7 studies evaluated subjective symptoms and showed that autologous serum eye drops were superior to ocular lubricants in alleviating and remitting symptoms. It was shown that autologous serum eye drops significantly improved parameters such as OSDI (Ocular Surface Disease Index), tear break-up time, and Bengal Rose staining when compared to the control group using ocular lubricants. Given the numerous properties of autologous serum eye drops, there is no doubt about their benefit and effectiveness in treating several ocular surface diseases, including ocular GVHD. However, the difficulty in accessing production and the substantial cost of autologous serum eye drops are the main challenges, and their use is often limited to more severe dry eye cases and those refractory to conventional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Production of autologous serum in a closed system for ocular use | Experimental | Drug: Autologous Serum 20% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years
- Dry eye and/or chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;
- Peripheral venous access or PICC that allows the collection of whole blood.
Key exclusion criteria (10 listed)
- Active ocular infection;
- Hemoglobin < 11 g/dL;
- Angina, MI, or stroke in the last 30 days;
- Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;
- Active ocular or systemic infection at the time of collection;
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 |
|---|---|---|
| Autologous Serum 20%The collection of autologous serum in a closed blood processing system for ocular use | Drug | Production of autologous serum in a closed system for ocular use |
Primary outcome
Feasibility of using the collection device under testing
Time frame: 2 years
Proportion of blood collections that resulted in successful production of final autologous serum containers suitable for patient use.
18 secondary outcomes
Median pre-freezing number of leukocytes in autologous serum
Time frame: 2 years
Median pre-freezing number of red blood cells in autologous serum
Time frame: 2 years
Median pre-freezing number of platelets in autologous serum
Time frame: 2 years
Median pre and post-freezing pH in autologous serum
Time frame: 2 years
Pre-freezing microbiological test of autologous serum
Time frame: 2 years
NIH ocular score
Time frame: baseline, 6 weeks, 12 weeks, and end of treatment
Ocular Surface Disease Index
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Global ocular symptom score
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Lee score ocular subscale
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Corneal staining score (fluorescein)
Time frame: Baseline, 6 weeks, 12 weeks
Corneal staining score (Rose Bengal)
Time frame: Baseline, 6 weeks, 12 weeks
Meibography
Time frame: Baseline, 6 weeks, 12 weeks
Schirmer test
Time frame: Baseline, 6 weeks, 12 weeks
Non-invasive tear film break-up
Time frame: Baseline, 6 weeks, 12 weeks
Tear film lipid layer
Time frame: Baseline, 6 weeks, 12 weeks
Adherence to the use of autologous serum
Time frame: At 6 and 12 weeks post-treatment
Patient's qualitative evaluation of the use of autologous serum
Time frame: At 12 weeks post-treatment
Team's qualitative perception of the feasibility of collection and production of autologous serum
Time frame: At 50% of planned recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Serum 20% in people with GVHD and Meibomian Gland Dysfunction (Disorder), run by GIANCARLO FATOBENE at 1 site in Brazil.
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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of using the collection device under testing (time frame: 2 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 21 Oct 2026.