Autologous Serum Obtained by a Closed-Circuit Collection Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Serum 20%.
- Who it may be relevant to
- Registry conditions: GVHD, Meibomian Gland Dysfunction (Disorder), Stevens-Johnson Syndrome, Limbal Keratoconjunctivitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
"In Vivo Evaluation of Topical Ocular Use of Autologous Serum Obtained by a Closed-Circuit Collection Device."
Overview
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.
Interventions
- Drug Autologous Serum 20%
The collection of autologous serum in a closed blood processing system for ocular use
Primary outcome measures
- Feasibility of using the collection device under testing [Time frame: 2 years]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- ≥ 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.
Exclusion criteria
- 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;
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- HCFMUSP — São Paulo
Identifiers
NCT: NCT07014059 · 78127624.4.0000.0068