Plasmapheresis for Frailty

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Pregnancy, Terminal illness, Syphilis, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether plasmapheresis (also known as Therapeutic Plasma Exchange or TPE) can improve physical, mental, and immune health in people with age-related frailty. Plasmapheresis filters blood to replace plasma, potentially boosting overall function. Participants will receive the treatment once a month for six months. The trial seeks individuals who feel physically weaker and struggle with daily tasks due to frailty, not another condition. As an Early Phase 1 trial, this research focuses on understanding how plasmapheresis works in people, offering participants the chance to explore its potential benefits.

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 prior data suggests that this plasmapheresis treatment is safe for age-related frailty?

Research has shown that therapeutic plasma exchange (TPE) is generally safe for older adults. One study on age-related conditions found that elderly participants tolerated standard plasma exchange well, with no serious side effects. Another study indicated that TPE can safely lower biological age markers by up to 2.6 years, suggesting the procedure poses no significant safety risk.

This trial is in its early stages, and these initial results typically indicate that more research is needed to confirm safety and effectiveness. However, existing evidence on TPE in similar age groups provides a positive view of its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for age-related frailty, such as exercise programs and nutritional supplements, Therapeutic Plasma Exchange (TPE) acts on a different mechanism. TPE involves removing and replacing a person's plasma, which may help eliminate harmful substances that contribute to frailty. Researchers are excited about TPE because it offers a novel approach by potentially rejuvenating the body's systems and addressing the underlying biological factors of frailty, rather than just managing symptoms. This innovative method could lead to improved strength and vitality in older adults.

What evidence suggests that plasmapheresis might be an effective treatment for frailty?

Research suggests that plasmapheresis, a process that filters the liquid part of the blood, might help treat age-related frailty. One study found that this treatment can change certain aging-related indicators in the body, such as alkaline phosphatase and albumin levels. Although a proven cure for frailty does not yet exist, early results indicate that plasmapheresis might influence biological age, showing potential benefits. While this treatment is still in the early stages for frailty, changes in these indicators offer a hopeful sign of its effectiveness. Participants in this trial will receive plasmapheresis once a month for six months to further evaluate its impact on age-related frailty. ^{2 6 7 8 9}

Who Is on the Research Team?

Sheldon Jordan, MD

Principal Investigator

Neurological Associates The Interventional Group

Are You a Good Fit for This Trial?

This trial is for people aged 50-95 showing signs of age-related frailty, which includes weakened physical, cognitive, and immune functions. Participants must score between 3 and 7 on the CSHA Clinical Frailty Scale. It's not open to pregnant or breastfeeding women, those with terminal illnesses, syphilis, inability to lay still for long periods, or with rashes/open wounds.

Inclusion Criteria

Clinical appraisal by physician indicating signs of frailty (apart from a co-occurring condition), scoring 3<x <7 as denoted by the CSHA Clinical Frailty Scale (see Appendix A; Rockwood, Song, MacKnight, et al, 2005; Golpanian, DiFede, Pujol, et al., 2016)

I am between 50 and 95 years old.

Exclusion Criteria

I can't stay still enough to fall asleep in a calm environment.

I have a rash or open wounds, possibly from skin cancer treatment.

Subjects with a reactive serologic test positive for Syphilis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive plasmapheresis once a month for six months

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Weekly follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Therapeutic Plasma Exchange (TPE)

Trial Overview The study tests how effective plasmapheresis (filtering blood plasma) is in treating age-related frailty using a machine called 'Amicus'. The process involves replacing a patient's plasma with albumin solution to see if it improves their condition.

How Is the Trial Designed?

Group I: Experimental Group (Plasmapheresis for Age-Related Frailty) Experimental Treatment 1 Intervention

Participants will receive plasmapheresis once a month for six months. All participants will be in this arm.

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05054894

Plasmapheresis for Treatment of Age-Related Frailty To date, there is no proven effective therapy or cure for age-related frailty. There is an urgent need to address the burden of frailty with possible ...

2. 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11270162/

Efficacy and Safety of Rescue Treatment with Plasma ... After TPE, the mRS score was globally reduced (p < 0.0001), and this effect was marked in patients with MS, Guillain–Barré syndrome, and ...

4. withpower.com withpower.com/trial/early-phase-1-frailty-2-2021-7948e?lat=36.65114&lng=-97.3517

Plasmapheresis for Frailty · Info for Participants Trial Overview The study tests how effective plasmapheresis (filtering blood plasma) is in treating age-related frailty using a machine called 'Amicus'. The ...

5. medicalxpress.com medicalxpress.com/news/2025-05-clinical-trial-impact-therapeutic-plasma.html

Clinical trial demonstrates the impact of therapeutic plasma ... The results provide early data on the impact of TPE on biological age, supporting its potential for new disease and longevity applications.

6. semanticscholar.org semanticscholar.org/paper/e1bee013032517f699afce5a3c6bd078a7678081

[PDF] The use of therapeutic plasmapheresis in preventive ... The use of plasmapheresis with albumin replacement in randomly selected male and female patients will help reduce the biological age of patients and, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05054894

Plasmapheresis for Treatment of Age-Related Frailty This study is designed to evaluate the efficacy of albumin-infused plasmapheresis, using the Fresenius Kabi 'Amicus' apheresis machine, among patients with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10041617/

Therapeutic efficacy and safety of plasmapheresis in elderly ... This retrospective study assessed the efficacy and safety of standard plasma exchange (PLEX) treatment in an elderly population with NMOSD. Design: Seventy-six ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acel.70103

Multi‐Omics Analysis Reveals Biomarkers That Contribute ... Therapeutic plasma exchange safely reduces biological age by up to 2.6 years. Multi-omics analysis reveals coordinated cellular and ...