Plasma Exchange for Aging

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Dobri Kiprov

Disqualifiers: Active malignancy, Alzheimer's, coronary disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3-6 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to assure the safety of long term therapeutic plasma exchange (TPE) with and without Intravenous Immunoglobulin (IVIG) and its effects on biomarkers and epigenetic biologic clocks in forty individuals. The main question is to assure the safety from long term TPE using changes in clinical and laboratory outcomes and also evaluating changes on additional blood biomarkers and epigenetic clocks during and after TPE treatment. Researchers will compare the TPE treatment group to the Sham treatment group to identify changes due to TPE. Participants will receive six TPE or Sham treatments over one of two treatment schedules and may receive IVIG with treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Plasma Exchange for Aging?

Therapeutic Plasma Exchange (TPE) has been used effectively in treating various diseases by removing harmful substances from the blood, as shown in studies involving both neurologic and non-neurologic conditions. This suggests that TPE could potentially be beneficial for aging-related conditions by similarly removing unwanted proteins or molecules from the blood. ^{1 2 3 4 5}

Is plasma exchange generally safe for humans?

Therapeutic plasma exchange (TPE) is generally considered safe in adults, but there are concerns about its safety in children and the elderly due to potential complications. It is important to have experienced medical professionals perform the procedure to minimize risks. ^{1 6 7 8 9}

How is the treatment Therapeutic Plasma Exchange unique for aging?

Therapeutic Plasma Exchange (TPE) is unique because it involves removing and replacing the plasma in the blood to eliminate harmful substances, which is different from typical treatments that might focus on medication or lifestyle changes. This method is not commonly used for aging, making it a novel approach in this context. ^{1 2 3 6 10}

Research Team

Dobri Kiprov, MD

Principal Investigator

Global Apheresis

Eligibility Criteria

This trial is for forty individuals interested in the safety and effects of long-term plasma exchange on aging. Specific eligibility criteria are not provided, but typically participants would need to be healthy enough for the procedures involved.

Inclusion Criteria

I am over 50, with or without a chronic inflammatory condition.

Exclusion Criteria

Psychiatric disorder that will interfere with participation in the study (e.g., schizophrenia, bipolar disorder)

I currently have an active infection.

I have difficulty with blood draws or IV access due to poor veins.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six TPE or Sham treatments over one of two treatment schedules, with optional IVIG administration

3-6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in clinical and laboratory outcomes

1 year

Treatment Details

Interventions

• Intravenous Immunoglobulin
• Sham
• Therapeutic Plasma Exchange

Trial Overview The study tests if long-term therapeutic plasma exchange (TPE), with or without Intravenous Immunoglobulin (IVIG), is safe and how it affects age-related biomarkers and epigenetic clocks. Participants will receive six TPE or Sham treatments over two different schedules, some may also get IVIG.

Participant Groups

Group I: TPE Monthly Active Control 1 Intervention

will receive 6 monthly TPE procedures (TOTAL 6 treatments)

Group II: TPE Bimonthly with IVIG Active Control 2 Interventions

will receive 2 TPE procedures followed by 2 gm of IVIG in one week. The same treatment will be repeated on a monthly basis twice more. (Two TPE procedures per month for three months - total of 6 treatments)

Group III: TPE Bimonthly Active Control 1 Intervention

will receive 2 TPE procedures in one week. The same treatment will be repeated on a monthly basis two more times (Two treatments per month for three months to total 6 treatments)

Group IV: Sham Placebo Group 1 Intervention

Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments)

Therapeutic Plasma Exchange is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Therapeutic Plasma Exchange for:

• Thrombotic thrombocytopenic purpura
• Guillain-Barré syndrome
• Multiple sclerosis
• Chronic inflammatory demyelinating polyradiculoneuropathy
• Lambert-Eaton syndrome
• Myasthenia gravis
• Goodpasture syndrome

Approved in United States as Therapeutic Plasma Exchange for:

• Thrombotic thrombocytopenic purpura
• Guillain-Barré syndrome
• Multiple sclerosis
• Chronic inflammatory demyelinating polyradiculoneuropathy
• Lambert-Eaton syndrome
• Myasthenia gravis
• Goodpasture syndrome
• Sepsis with multiorgan failure

Approved in Canada as Therapeutic Plasma Exchange for:

• Thrombotic thrombocytopenic purpura
• Guillain-Barré syndrome
• Multiple sclerosis
• Chronic inflammatory demyelinating polyradiculoneuropathy
• Lambert-Eaton syndrome
• Myasthenia gravis
• Goodpasture syndrome

Who Is Running the Clinical Trial?

Dobri Kiprov

Lead Sponsor

Trials

1

Recruited

40+

CIRCULATE, Inc.

Collaborator

Trials

1

Recruited

40+

Findings from Research

In a study of 42 patients undergoing 104 therapeutic plasma exchange (TPE) procedures, 75% showed improvement in their conditions, indicating that TPE is an effective treatment for diseases involving pathological proteins.

The most common conditions treated were polyradiculoneuropathies, myasthenia gravis, and Guillain-Barré syndrome, with the procedures primarily performed using a specific blood separator and citrate as an anticoagulant, highlighting the method's safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic plasma exchange in Casablanca. Tazi, I., Merimi, F., Majd, A., et al.[2008]

Therapeutic Plasma Exchange (TPE) by filtration is considered a safe procedure with mild and manageable complications, such as thrombocytopenia (41%), hypocalcemia (18%), and hypotension (16%).

Despite its safety, the one-year mortality rate was 30%, primarily due to severe underlying conditions like pulmonary-renal syndrome and ANCA vasculitis, indicating that TPE is often used in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic plasma exchange. Experience in 102 patients]. Ramírez-Guerrero, G., Müller-Ortiz, H., Jara-Vilugrón, F., et al.[2022]

Therapeutic Plasma Exchange (TPE) was performed on 161 patients over nine years, primarily for treating Guillain-Barre Syndrome (67.7%), and showed a 9.93% incidence of adverse reactions, indicating it is a generally safe procedure.

TPE demonstrated effectiveness as a treatment for neurological disorders, providing a viable alternative to Intravenous Immunoglobulin (IVIG), particularly in improving outcomes for conditions like Guillain-Barre Syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Plasma Exchange - An Emerging Treatment Modality in Patients with Neurologic and Non-Neurologic Diseases. Bobati, SS., Naik, KR.[2020]

Therapeutic plasma exchange (TPE) is effective for critically ill children, particularly for autoimmune neurological diseases, with a complete response rate of 64% and an overall survival rate of 92% at discharge from the pediatric intensive care unit (PICU).

Complications from TPE are generally mild, occurring in 17.4% of sessions, with transient hypotension being the most common issue, and there were no significant differences in outcomes between the two methods of TPE (centrifugation vs. membrane-based).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic plasma exchange in critically ill children: experience of the pediatric intensive care unit of two centers in Chile. Bustos B, R., Hickmann O, L., Cruces R, P., et al.[2022]

In a study of 230 patients undergoing therapeutic plasma exchange (PE) for neurological disorders, primarily Guillain-Barré Syndrome (GBS), the procedure was found to be safe with no reported mortality over a 48-month period.

The most common complications were minor, including paraesthesias and cramps (36.1%) and hypotension (32.2%), indicating that while some side effects occurred, they were not severe and did not lead to serious outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasmapheresis in neurological disorders: Experience from a tertiary care hospital in South India. Gafoor, VA., Jose, J., Saifudheen, K., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Therapeutic plasma exchange in Casablanca. [2008]

2. Chile pubmed.ncbi.nlm.nih.gov

[Therapeutic plasma exchange. Experience in 102 patients]. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Therapeutic Plasma Exchange - An Emerging Treatment Modality in Patients with Neurologic and Non-Neurologic Diseases. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Patients treated with therapeutic plasma exchange: a single center experience. [2014]

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

Therapeutic plasma exchange in critically ill children: experience of the pediatric intensive care unit of two centers in Chile. [2022]

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

Therapeutic Plasma Exchange-Does Age Matter? A Single-Center Study. [2017]

7. India pubmed.ncbi.nlm.nih.gov

Therapeutic plasma exchange in pediatric patients of Guillain-Barre syndrome: Experience from a Tertiary Care Centre. [2020]

8. India pubmed.ncbi.nlm.nih.gov

Plasmapheresis in neurological disorders: Experience from a tertiary care hospital in South India. [2022]

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

Therapeutic plasma exchange in children: One center's experience. [2018]

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

Therapeutic plasma exchange: Experience in a third level hospital, 2013-2016, Lima (Peru). [2018]