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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of Therapeutic Plasma Exchange (TPE) on aging-related blood markers. Participants will receive TPE with or without an additional treatment called Intravenous Immunoglobulin (IVIG), and their results will be compared to those receiving a sham (fake) treatment. It is designed for individuals over 50, regardless of whether they have a chronic inflammatory condition. However, the trial is not suitable for those with poor blood flow in their arms, active cancer, or severe heart or lung diseases. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that therapeutic plasma exchange (TPE) is generally safe and well-tolerated. In some studies, minor issues occurred in 20-30% of participants, but these were not serious. The risk of a serious problem, such as death, is extremely low, ranging from 0.0009% to 0.0017%. Some individuals, particularly older adults, might experience low blood pressure during the procedure, but this usually resolves quickly.

For intravenous immunoglobulin (IVIG), research also supports its safety in older adults. Reactions may occur depending on the specific IVIG used, often related to the administration method. There is a risk of kidney problems, especially with certain types, but serious issues are rare.

Overall, both TPE and IVIG have strong safety records, particularly when carefully monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Therapeutic Plasma Exchange (TPE) for aging because it offers a novel approach compared to traditional anti-aging treatments, which typically involve lifestyle changes or medications targeting specific symptoms. TPE works differently by removing and replacing plasma, potentially clearing harmful substances that accumulate with age. This trial explores various TPE methods, including monthly treatments, bimonthly sessions with or without immune-boosting IVIG, which could lead to more personalized and effective anti-aging strategies. By directly altering the components of blood, TPE might address aging at a systemic level rather than just treating individual symptoms.

What evidence suggests that this trial's treatments could be effective for aging?

Research has shown that therapeutic plasma exchange (TPE) can positively affect aging by altering certain markers linked to aging. In this trial, participants may receive TPE combined with intravenous immunoglobulin (IVIG). Previous studies have demonstrated that this combination reduces the biological age of participants by an average of 2.6 years. Another arm of this trial involves monthly TPE alone, which studies have found reduces biological age by about 1.32 years. TPE also appears to refresh the immune system and reduce inflammation, both crucial for slowing aging effects. Overall, these findings suggest that TPE could help with age-related changes. ^{6 7 8 9 10}

Who Is on the Research Team?

Dobri Kiprov, MD

Principal Investigator

Global Apheresis

Are You a Good Fit for This Trial?

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.

Alcohol or drug dependency

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12218284/

Human clinical trial of plasmapheresis effects on biomarkers ... Based on their results, they concluded that the procedure altered the levels of biomarkers associated with aging (alkaline phosphatase, albumin, ...

2. buckinstitute.org buckinstitute.org/news/clinical-trial-and-multi-omics-analysis-demonstrates-the-impact-of-therapeutic-plasma-exchange-on-biological-age/

Clinical Trial and Multi-omics Analysis Demonstrates the ... Study in Aging Cell shows that therapeutic plasma exchange combined with intravenous immunoglobulin reduced biological age on average by 2.6 years.

3. lifespan.io lifespan.io/news/how-plasma-exchange-affects-aging-in-a-human-trial/

How Plasma Exchange Affects Aging in a Human Trial The TPE + IVIG group experienced a reduced average biological age of 2.61 years, while this number was 1.32 for the monthly TPE group.

4. mdpi.com mdpi.com/2218-273X/15/7/1000

Therapeutic Plasma Exchange: Current and Emerging ... TPE is a blood purification technique which functions to remove pathological plasma constituents such as autoantibodies, inflammatory cytokines, immune ...

5. cbs42.com cbs42.com/business/press-releases/ein-presswire/825390972/human-study-reveals-therapeutic-plasma-exchange-tpe-reverses-biological-aging

Human Study Reveals Therapeutic Plasma Exchange ... TPE with IVIG also rejuvenated immune system profiles and significantly reduced inflammation—key factors in slowing age-related decline.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26467654/

Safety of intravenous immunoglobulin in the elderly treated ... In the elderly, IVIg infusions are safe. Adverse reactions mainly depend on IVIg preparation and administration. Renal failure is not uncommon with sugar-free ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2666

Safety outcomes of intravenous immunoglobulin (IVIG) in ... 81% (25/31) had grade 3 or 4 pneumonitis at the time of IVIG therapy. In-hospital death occurred in 41% (13/31). Majority of in-hospital death ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37171778/

Intravenous Immunoglobulin Treatment Patterns and ... Real-world IVIG treatment patterns and treatment and safety outcomes (assessed via ICD codes) were described. Results: In total, 3975 patients ...

9. annallergy.org annallergy.org/article/S1081-1206(24)01506-0/fulltext

Outcomes of intravenous immunoglobulin treatment ... Secondary clinical outcomes included hospital readmission within 30 days of discharge, death during hospitalization, and serious adverse effects ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1521661625000324

The efficacy and safety between efgartigimod ... Among 74 enrolled patients, efgartigimod showed greater reduction in MG-ADL scores compared to IVIg at weeks 4 and 8, with no serious adverse events, suggesting ...