FrontlineODP™ Spray Dried Plasma for Blood Clotting Disorders

Recruiting at 2 trial locations

Overseen By Lisa Buckley, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Velico Medical

Must not be taking: Antibiotics, Anticoagulants, Aspirin

Disqualifiers: Cancer, Hypertension, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP).

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as antibiotics, medications for infections, aspirin, platelet-inhibiting agents, and anticoagulant therapy. If you're taking any of these, you may need to stop before participating.

What data supports the effectiveness of the treatment FrontlineODP™ Spray Dried Plasma for blood clotting disorders?

Spray-dried plasma, like FrontlineODP™, is effective because it can be easily transported and stored at room temperature, making it quickly available for use in emergencies. Studies have shown that similar spray-dried plasma products help manage bleeding by providing essential blood clotting factors, similar to fresh frozen plasma, but with added logistical benefits. ^{1 2 3 4 5}

How is FrontlineODP™ Spray Dried Plasma different from other treatments for blood clotting disorders?

FrontlineODP™ Spray Dried Plasma is unique because it can be stored at room temperature and quickly reconstituted, making it easier to transport and use in emergency situations compared to traditional fresh frozen plasma, which requires freezing and thawing. ^{1 2 3 4 6}

Research Team

Mark Popovsky, MD

Principal Investigator

Velico Medical

Eligibility Criteria

Healthy volunteers aged 18-65 who can consent, understand English, have completed COVID-19 vaccination, and meet specific weight requirements. Women must not be pregnant/breastfeeding and should use effective contraception or be sterile. Participants must feel well and score ≥35 on the Duke Activity Status Index.

Inclusion Criteria

I am a female weighing between 140-220 pounds or a male weighing between 140-250 pounds.

Subject is able to donate plasma by plasmapheresis based on AABB Donor History Questionnaire with modifications

Subject has read educational materials on donating blood and had questions answered

Exclusion Criteria

I have cancer.

Subject is institutionalized

Subject has a history of asthma

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Plasmapheresis Collection

Subjects undergo plasmapheresis to collect plasma for re-infusion

1 week

1 visit (in-person)

Infusion

Participants receive infusions of rehydrated plasma (FrontlineODP or PF24)

2 weeks

2 visits (in-person) with a 14-day washout period between infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• FrontlineODP™ Spray Dried Plasma

Trial Overview The trial is testing FrontlineODP™ Spray Dried Plasma in healthy individuals to see if different doses are safe when infused into the body. It's for people with bleeding or blood clotting disorders.

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection, in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 2 units (400 mL) of autologous FrontlineODP.

Group II: Cohort 1 Experimental Treatment 1 Intervention

Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 1 unit (200 mL) of autologous FrontlineODP.

Group III: Cohort 3 Arm 3 Active Control 1 Intervention

Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous FrontlineODP and 4 units of autologous control PF24. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 3 will receive 4 units of FrontlineODP during the first infusion visit, and following a 14 day washout period, they would receive 4 units of PF24 during a second visit.

Group IV: Cohort 3 Arm 4 Active Control 1 Intervention

Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous control PF24 and 4 units of autologous FrontlineODP. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 4 will receive 4 units of PF24 during the first infusion visit, and following a 14 day washout period, they would receive 4 units of FrontlineODP during the second visit.

Who Is Running the Clinical Trial?

Velico Medical

Lead Sponsor

Trials

2

Recruited

80+

Findings from Research

Solvent/detergent-treated plasma (SDP) and fresh-frozen plasma (FFP) have similar levels of most coagulation factors, but FFP contains significantly higher concentrations of factors V, von Willebrand factor, and ADAMTS-13, which are important for blood clotting.

Cytokine levels, including TNF-α, IL-8, and IL-10, were also higher in FFP compared to SDP, indicating that FFP may have a broader range of immune response factors, although the clinical significance of these differences needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative concentrations of haemostatic factors and cytokines in solvent/detergent-treated and fresh-frozen plasma. Theusinger, OM., Baulig, W., Seifert, B., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Freeze-dried plasma for major trauma - Systematic review and meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Single-donor spray-dried plasma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Spray-dried plasma and fresh frozen plasma modulate permeability and inflammation in vitro in vascular endothelial cells. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Development and testing of low-volume hyperoncotic, hyperosmotic spray-dried plasma for the treatment of trauma-associated coagulopathy. [2011]

5. England pubmed.ncbi.nlm.nih.gov

Relative concentrations of haemostatic factors and cytokines in solvent/detergent-treated and fresh-frozen plasma. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Pre-hospital intra-osseous freeze dried plasma transfusion: a case report. [2020]