FrontlineODP™ Spray Dried Plasma for Blood Clotting Disorders

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new spray-dried plasma treatment for blood clotting disorders. Healthy volunteers will receive different doses to assess how their bodies respond. This opportunity helps researchers determine the treatment's safety and potential effectiveness. Candidates should feel healthy, weigh over 140 pounds, and maintain a regular exercise routine. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that FrontlineODP™ Spray Dried Plasma is likely to be safe for humans?

Researchers are conducting studies to understand the safety of FrontlineODP™ Spray Dried Plasma in humans. Previous studies have shown that the proteins in this plasma, which help blood clot, are mostly within normal human levels, with a slight decrease of about 10%–20%. This suggests the treatment might function similarly to regular plasma.

This trial is in an early phase, focusing on safety in healthy volunteers. Although there isn't much safety data yet, early-phase trials aim to identify any possible side effects and assess how well people tolerate the treatment. If the FDA had already approved the treatment for another condition, it might indicate some known safety, but that's not the case here. Overall, the safety is still under investigation, but testing in healthy individuals is an important step in gaining more insight. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about FrontlineODP™ Spray Dried Plasma because it offers a novel approach to treating blood clotting disorders. Unlike traditional treatments that often rely on fresh frozen plasma, FrontlineODP™ is a spray-dried plasma product, which can be stored more easily and has an extended shelf life. This makes it potentially more accessible and easier to use in emergency situations or locations with limited resources. Additionally, the product is autologous, meaning it is derived from the patient's own blood, reducing the risk of immune reactions. This innovative approach could improve safety and convenience while maintaining effectiveness in managing clotting issues.

What evidence suggests that this trial's treatments could be effective for blood clotting disorders?

Studies have shown that spray-dried plasma products, such as FrontlineODP, help control bleeding by providing essential blood clotting factors, similar to those in fresh frozen plasma. Research indicates that the blood clotting factors in spray-dried plasma are nearly as effective as those in human blood, with only a slight reduction compared to fresh plasma. Despite this, experts consider spray-dried plasma just as safe and effective as standard frozen plasma. This trial will evaluate FrontlineODP in various treatment arms, suggesting it could be a viable option for treating blood clotting disorders. ^{1 3 4 5 6}

Who Is on the Research Team?

Mark Popovsky, MD

Principal Investigator

Velico Medical

Are You a Good Fit for This Trial?

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

Subject is institutionalized

I have cancer.

Subject has a history of asthma

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05629338

Ascending Dose Study of FrontlineODP™ Spray Dried ... This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP).

2. withpower.com withpower.com/trial/phase-1-coagulation-disorder-11-2022-491db

FrontlineODP™ Spray Dried Plasma for Blood Clotting ... Studies have shown that similar spray-dried plasma products help manage bleeding by providing essential blood clotting factors, similar to fresh frozen plasma, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12088305/

Coagulation factors in spray‐dried plasma - PubMed Central In studies that reported tests of coagulation function, prothrombin time (PT) was significantly longer with SDP by 7.5% (pooled MD 0.85 secs; 95% CI: 0.16–1.53) ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/vox.13798

An experimental comparison and user evaluation of three ... The coagulation factor content was within human reference ranges for all dried plasma, with approximately 10%–20% loss compared with fresh ...

5. aabb.org aabb.org/news-resources/news/article/2025/10/26/aabb2025--spray-dried-plasma-may-offer-viable-alternative

AABB2025: Spray-Dried Plasma May Offer Viable Alternative Spray-dried plasma appears to be comparable in safety and potency to standard frozen plasma, according to new data presented during the oral ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124053989

Characterization and Stability of Spray Dried Plasma ... The FrontlineODP™ System is a novel, decentralized, manufacturing technology designed for use by blood centers for producing spray dried plasma ...