What side effects are associated with this type of intervention?

The treatment of plasminogen deficiency with allogenic plasma (plasminogen supplementation) has shown effectiveness in preventing the recurrence of pseudomembranous lesions, particularly in the eyes. While specific side effects of this treatment are not detailed in the provided context, general side effects of plasma administration can include allergic reactions, infections, and transfusion-related complications. Close monitoring is essential to manage any adverse effects that may arise during the treatment period.

What prior FDA approvals exist?

The FDA has approved treatments for plasminogen deficiency that focus on plasminogen supplementation. These treatments aim to address impaired wound healing and the growth of pseudomembranous lesions, particularly in the eyes. While specific FDA-approved drugs for plasminogen deficiency are not detailed, the use of plasminogen, either as a concentrate or through allogenic plasma, has shown effectiveness in preventing the recurrence of these lesions. This approach is similar to the ongoing studies using aliquoted allogenic plasma for intra-ocular application.

What other types of research exist?

Promising novel alternatives to allogenic plasma for plasminogen deficiency patients include recombinant plasminogen therapies and gene therapy approaches. Recombinant plasminogen is being developed to provide a more consistent and controlled treatment option. Gene therapy aims to correct the underlying genetic defect, potentially offering a long-term solution. Both approaches are currently under investigation and show potential for future clinical use.

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Plasma

Plasminogen Therapy for Pink Eye

Q: What is the mechanism of action of this treatment?

Plasminogen deficiency, which impairs wound healing and leads to the growth of pseudomembranous lesions, is commonly treated with plasminogen supplementation. This treatment involves administering plasminogen, either as a concentrate or through allogenic plasma, to restore normal plasminogen levels in the body. Plasminogen is crucial for the breakdown of fibrin in blood clots, and its deficiency can lead to abnormal tissue growth and scarring, particularly in the eyes (ligneous conjunctivitis). By supplementing plasminogen, these treatments help prevent the recurrence of lesions and promote proper wound healing, thereby preserving vision and preventing blindness in affected patients.

N/A

Recruiting

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ocular involvement (Ligneous Conjunctivitis) due to plasminogen deficiency

Diagnosis of plasminogen deficiency (clinical presence of pseudomembranous lesions and serum plasminogen level < 50%)

Must not have

Patients with no plasminogen deficiency

Patients with no ocular manifestations of plasminogen deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses small amounts of donated blood plasma applied to the eyes to treat patients with recurrent eye lesions caused by congenital plasminogen deficiency. The plasma contains a protein that helps dissolve and prevent these lesions.

Who is the study for?

This trial is for children under 18 with Ligneous Conjunctivitis, a type of pink eye caused by plasminogen deficiency. They must have pseudomembranous lesions and low serum plasminogen levels (<50%). It's not for adults or those without this specific condition.

What is being tested?

The study tests the use of donor plasma applied directly to the eyes of kids with Ligneous Conjunctivitis. The treatment lasts 2-6 months based on how severe the disease is and how well the patient responds, with possible re-treatment if symptoms return.

What are the potential side effects?

While specific side effects are not listed, serious adverse events related to plasma application in eyes will be monitored closely and reported to Canadian Blood Services and Health Canada.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have eye inflammation due to low plasminogen levels.

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I have been diagnosed with plasminogen deficiency.

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I am under 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a plasminogen deficiency.

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I do not have eye symptoms due to plasminogen deficiency.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in the visual acuity of affected eye after topical administration of aliquoted allogenic plasma into affected conjunctiva.

Plasma Proteins

Number of participants with development of strabismus or other visual defects in affected eye

+1 more

Secondary study objectives

Time to development of recurrence of pseudomembranous lesions in the eye undergoing intervention.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention arm (aliquoted plasma application into the conjunctiva)Experimental Treatment1 Intervention

This is the only arm of the study. The intervention is administration of aliquoted plasma provided by Canadian Blood Services in eye droppers (3 ml aliquots in 7 ml vials) in the patient's conjunctiva. The duration of therapy can be 2 to 6 months depending on response The intra-ocular drops will be administered every 1-5 hours daily in the affected eye based on disease severity and may be repeated

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Plasminogen deficiency, which impairs wound healing and leads to the growth of pseudomembranous lesions, is commonly treated with plasminogen supplementation. This treatment involves administering plasminogen, either as a concentrate or through allogenic plasma, to restore normal plasminogen levels in the body. Plasminogen is crucial for the breakdown of fibrin in blood clots, and its deficiency can lead to abnormal tissue growth and scarring, particularly in the eyes (ligneous conjunctivitis). By supplementing plasminogen, these treatments help prevent the recurrence of lesions and promote proper wound healing, thereby preserving vision and preventing blindness in affected patients.

Impact of intravenous thrombolysis on short-term coronary revascularization rates. A meta-analysis.Management of prehospital thrombolytic therapy in ST-segment elevation acute coronary syndrome (<12 hours).