The Vaccine Injury Treatment Center of Excellence & Research: Clinical Trial Consortium is a pioneering initiative.

This collaborative effort brings together leading scientists, researchers, and healthcare professionals to focus on innovative Vaccine Injury/Adverse Reaction and Long Covid research, development, and clinical trials. By fostering a multidisciplinary approach, the consortium aims to accelerate the discovery of new treatments and improve existing ones, addressing both emerging issues and longstanding public health challenges. Furthermore, the center prioritizes ethical research practices and equitable access to treatments, ensuring that breakthroughs benefit communities worldwide.

Why are we fundraising? All clinical trials must go through “IRB approval” for clinical research. The cost is $3,500 for the IRB we are using. After approval, there are many grants available that we will apply for to fund the trials. It is a completely decentralized consortium independent of all external influences.

Since the consortium is a voluntary association, Liberty Speaks, Inc., a 501C4, has stepped up to be the fundraising sponsor to help with IRB fees. Once IRB approved, each clinical trial will submit for grant money for the actual trial.

Below are brief summaries of the 7 different clinical trials that are being developed. Our consortium is made up of mostly physicians and allied health professionals as well as other non-medical team members of more than 50 people.

1. Japan A trial. We are trying to bring this to the U.S. as a clinical trial. This is a protocol from Japan using Stem Cells and Plasma Adsorption Therapy. Both aspects of the treatment are not FDA approved in the U.S. There are many hurdles to bringing this to the U.S.

"Plasma Adsorption Therapy Combined with Cultured Supernatant of Primary Tooth Pulp Stem Cells for Adverse Reactions Following COVID-19 mRNA Vaccination, with an Embedded Preclinical Translational Neuroscience Arm"

This study investigates the therapeutic effects of plasma adsorption therapy (DFPP) combined with intravenous administration of cultured supernatant derived from primary tooth pulp stem cells (SGF) in patients experiencing adverse reactions following COVID-19 mRNA vaccination. The human clinical component evaluates changes in circulating amyloidogenic proteins, inflammatory mediators, and clinical symptomatology before and after treatment.

2. Japan B trial. Variant of the protocol from Japan A trial using Stem Cells and specialized plasma exchange.

"Plasma exchange Combined with Umbilical Cord Stem Cells for Adverse Reactions Following COVID-19 mRNA Vaccination" This study investigates the therapeutic effects of specialized plasma exchange combined with intravenous administration of umbilical stem cells in patients experiencing adverse reactions following COVID-19 mRNA vaccination. The human clinical component evaluates changes in circulating amyloidogenic proteins, inflammatory mediators, and clinical symptomatology before and after treatment. This trial is intended to be similar to the Japan A trial using components that are already FDA approved in the U.S.

3. Physiologic Optimization trial "A Multi-Site Pragmatic Trial Evaluating Foundational Physiologic Optimization, Spike Detoxification, PicoIV Therapy, and Plasmalogen/ProdromeScan Testing in Long-COVID and Vaccine-Injured Patients, With Immune, Genomic, Thermographic, and Lipidomic Stratification"

Treatment Arms

Arm A – Foundational Optimization + Spike Detox, Vitamin D, thyroid/hormone optimization, nattokinase, bromelain, curcumin, ivermectin (if appropriate).

Arm B – Foundational Optimization + PicoIV, PicoIV 1–2× weekly or per standardized protocol.

Arm C – Foundational Optimization + Plasmalogen Therapy Guided by ProdromeScan. (Clinic offers plasmalogen therapy but has not yet had patients initiate).

Arm D – Combined PicoIV + Plasmalogen Therapy. Full integration of both modalities with ProdromeScan guidance.

4. Multimodal trial

Evaluation of a Multimodal Clinical Management Protocol for Patients Reporting Adverse Persistent Symptoms Following COVID-19 Vaccination or Significant Occurrence of Unvaccinated SARS-CoV-2 Infection: A Prospective Three-tier Observational and Interventional Cohort Study. A prospective, longitudinal, interventional, three-arm, open-label exploratory study.

Participants assigned by PI/participant preference (non-randomized) to one of:

Arm A: Investigational Pharmacologic + Nutraceutical/Botanical Combination

Arm B: Non-mainstream Bioactive/Physiologic Investigational Compounds

Arm C: Arm 2 + Emotional/Spiritual Supportive Modality

Follow-up: Baseline, 1-month, 3-month, 6-month.

Sample size: 80–150 participants.

5. Platelet Rich Plasma (PRP) trial

Use of Systemic Platelet Rich Plasma (PRP) Therapy to Manage COVID Vaccine Injuries. Each treatment will involve a check of the participant’s platelet count, placement of an IV, and the removal of 90-180cc of blood for processing. The exact amount of blood drawn will be determined by TruDose software, a proprietary software that has been developed for use in systemic PRP therapy. The blood will be spun in a centrifuge, and the platelet rich fraction will be extracted for each tube. These fractions will be combined and spun again to purify the fraction. The platelet count of this purified fraction will be determined, and the appropriate dose (using the TruDose software) will be administered via a slow IV push. Patients will also be pretreated for five days prior to the therapy with vitamin C and zinc. Treatments will be administered at baseline, two months, and four months with testing being done prior to the first treatment, two weeks after the four-month treatment, and at seven months from baseline. Statistical subgroups will include those with immune activation on cytokine testing (versus normal cytokines or low cytokines), the presence or absence of spike protein in monocytes or in serum, the presence of high (>1000) levels of IgG antibodies for SARS-CoV-2, and whether the populations of critical gut bacteria improve (primarily Bifidophilus and butyrate producing species). Because of the complexity of this population, we will target a study population of 60 participants.

6. Vedicinals and the McCullough Protocol trial

Evaluating Vedicinals and the McCullough Protocol for the Treatment of Long COVID and COVID-19 Vaccine Injury – A Multisite, Randomized, Active-Controlled Phase II/III Study. This multisite, phase II/III, randomized, active-controlled, parallel-group trial evaluates the comparative efficacy and safety of Vedicinals-9 versus the McCullough Base Spike Detoxification Protocol (nattokinase, bromelain, curcumin) in patients with Long COVID (post-acute sequelae of SARS-CoV-2 infection, PASC) or COVID-19 vaccine injury (spikeopathy). The study enrolls combined cohorts with stratification by condition to compare symptom reduction, biomarker changes, and mechanistic differences. Due to placebo challenges, an active-controlled design is used, relying on objective biomarkers to mitigate bias.

7. McCullough Protocol vs Placebo

The McCullough Protocol, or Base Spike Detoxification (BSD), is a detailed detox plan. The protocol includes a natural triple-agent oral regimen of nattokinase, bromelain, and curcumin that provides four putative, primary mechanisms of action: 1) proteolytic degradation of spike protein, 2) inhibition of inflammation from spike protein and its fragments in tissues, 3) dissolution of microthrombi, and 4) anticoagulation. Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination.

On the Horizon:

8. Confidential Study. Will be disclosed in a few months. Clinical trial is being drafted by two Co-PI's.

9. Clinical trial based on treatments for the IGE component of the Cytokine storm in the vaccinated.

Liberty Speaks Inc is a 501C4. Donations are not tax deductible. 100 percent of all donations for this campaign will go for IRB fees for the clinical trials and or clinical trials themselves.

The Vaccine Injury Treatment Center of Excellence & Research: Clinical Trial Consortium

Fundraiser to pay for IRB fees for initial 7 Draft Clinical Trials

Team Members