A Phase 2 interventional study of Autologous Serum 20% in GVHD, Meibomian Gland Dysfunction (Disorder) and Stevens-Johnson Syndrome, sponsored by GIANCARLO FATOBENE. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by GIANCARLO FATOBENE · Phase 2, Interventional, and Treatment
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.
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.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's planned enrollment of 16 is below the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →This is the only study on the registry with GIANCARLO FATOBENE as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Autologous Serum 20%
The collection of autologous serum in a closed blood processing system for ocular use
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.
Time frame: 2 years
Median pre-freezing number of leukocytes in autologous serum
0.0-0.03x10ˆ3/mcL;
Time frame: 2 years
Median pre-freezing number of red blood cells in autologous serum
0.0-0.03x10ˆ6/mcL;
Time frame: 2 years
Median pre-freezing number of platelets in autologous serum
0.0-0.03x10ˆ3/mcL;
Time frame: 2 years
Median pre and post-freezing pH in autologous serum
7.00-7.50;
Time frame: 2 years
Pre-freezing microbiological test of autologous serum
Positive or negative;
Time frame: 2 years
NIH ocular score
0-3
Time frame: baseline, 6 weeks, 12 weeks, and end of treatment
Ocular Surface Disease Index
Reported by the patient from 0 to 100
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Global ocular symptom score
Reported by the patient from 0 to 10
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Lee score ocular subscale
Reported by the patient from 0 to 100
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Corneal staining score (fluorescein)
Bijsterveld scale: 0-9.
Time frame: Baseline, 6 weeks, 12 weeks
Corneal staining score (Rose Bengal)
Bijsterveld scale: 0-9.
Time frame: Baseline, 6 weeks, 12 weeks
Meibography
Good, moderate, poor
Time frame: Baseline, 6 weeks, 12 weeks
Schirmer test
0-30 mm in 5 minutes
Time frame: Baseline, 6 weeks, 12 weeks
Non-invasive tear film break-up
0-50 seconds
Time frame: Baseline, 6 weeks, 12 weeks
Tear film lipid layer
0-3
Time frame: Baseline, 6 weeks, 12 weeks
Adherence to the use of autologous serum
Percentage of doses administered vs. planned doses: 0-100%
Time frame: At 6 and 12 weeks post-treatment
Patient's qualitative evaluation of the use of autologous serum
Qualitative questionnaire
Time frame: At 12 weeks post-treatment
Team's qualitative perception of the feasibility of collection and production of autologous serum
Qualitative questionnaire
Time frame: At 50% of planned recruitment
Pre- and post-growth factor in autologous serum
EGF, PDGF, NGF, Substance P, hialuronic acida, vitamin A and Vitamin D
Time frame: two years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Feb 2027, 19 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: primary completion Jun 2026 → Feb 2027 and completion Jun 2027 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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