{"type":"trials","record":{"id":20018,"source_id":"clinicaltrials-gov","external_id":"NCT07836127","title":"Human Albumin Combined With Plasma Exchange for Frailty Intervention","brief_summary":"Background Frailty is an age-related syndrome characterized by reduced physiological reserve, decreased stress tolerance and multisystem functional decline in the elderly, which markedly increases the risks of falls, hospitalization, functional impairment and all-cause mortality. Chronic low-grade inflammation, immune senescence, oxidative stress and abnormal protein modification are key mechanisms underlying the development and progression of frailty. Current mainstream interventions including nutritional support and physical exercise yield limited efficacy for moderate to severe frailty, and targeted therapies against biological aging mechanisms are still lacking.Objective To evaluate the efficacy and safety of plasma exchange combined with human albumin (ALB), with or without intravenous immunoglobulin (IVIg), in the treatment of frailty, and to preliminarily explore the potential mechanisms of the combined therapy.Methods This is a prospective, randomized, exploratory clinical trial. A total of 34 participants with a FRAIL scale score ≥ 1 will be enrolled and randomly assigned at a 1:1 ratio into two groups, with 17 cases in each group: the plasma exchange plus ALB group and the plasma exchange plus ALB plus IVIg group. The study consists of a screening phase, a 5-month treatment phase with six intervention sessions, and follow-up visits at 1, 3 and 6 months after the final treatment. Frailty status, physical function, laboratory parameters, inflammatory levels and albumin modification will be dynamically assessed throughout the trial, and adverse events will be recorded.Results The trial has not yet been initiated. It is expected that the within-group and between-group comparisons will clarify the therapeutic effects and long-term stability of the two regimens, as well as their safety profiles. Changes in biomarkers will help illustrate the potential molecular mechanisms of plasma purification combined with functional protein supplementation for frailty.Conclusion Plasma exchange combined with ALB (with or without IVIg) can exert multi-target intervention on frailty by eliminating aging-related toxic factors and restoring plasma and immune homeostasis. The findings of this study will provide preliminary clinical evidence and theoretical basis for novel biological therapeutic strategies for frailty.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","enrollment":34,"countries":["China"],"start_date":"2026-09-24","completion_date":"2028-11-14","last_update_date":"2026-09-23","source_url":"https://clinicaltrials.gov/study/NCT07836127","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-23T12:17:13.490236+00:00","last_seen_at":"2026-09-25T06:20:04.694+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years","comparator":null,"organization":"Institute of Hematology & Blood Diseases Hospital, China","interventions":["Plasma Exchange","5% human albumin","Intravenous immunoglobulin (IVIG)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Efficacy rate of frailty intervention at 1 month after the last treatment — 1 month after the last treatment","Efficacy rate of frailty intervention assessed by FRAIL Scale — Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24…","Strand specificity of frailty-related cfDNA and therapeutic response to plasma exchange — Baseline, 1 month and 6 month…","Clonal hematopoiesis gene mutation dynamics and correlation with frailty — Baseline, 4 week,24 week, 28 week, and 32 we…","BCR clonotype characteristics — Baseline, 1 month and 6 months after the last treatment","BCR V/J gene usage bias — Baseline, 1 month and 6 months after the last treatment","BCR diversity index — Baseline, 1 month and 6 months after the last treatment","Frequency of senescence-associated antigen-specific B cell clones — Baseline, 1 month and 6 months after the last treat…","TCR clonotype characteristics — Baseline, 1 month and 6 months after the last treatment","TCR diversity index — Baseline, 1 month and 6 months after the last treatment","TCR V/J gene usage bias — Baseline, 1 month and 6 months after the last treatment","Frequency of senescence-associated antigen-specific T cell clones — Baseline, 1 month and 6 months after the last treat…","Between-group differences in frailty scale score: ALB group vs ALB+IVIg group — Baseline, 4 week, 8 week, 12 week, 16 w…","Baseline changes of serum ALB modification at 1 month after last treatment — 1 month after the last treatment","Changes from baseline in senescence-related indicators at 1 month after last treatment — 1 month after the last treatme…","Changes from baseline in Tilburg Frailty Indicator (TFI) scores — Baseline, 4 week, 8 week, 12 week, 16 week, 20 week,…","Changes from baseline in Fried Frailty Phenotype Scale scores — Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24…","Changes from baseline in physical and mental health questionnaire scores — Baseline, 4 week, 8 week, 12 week, 16 week,…","Short Physical Performance Battery (SPPB) score — Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week…","Changes in gene mutation frequency and its correlation with immune cell subsets — Baseline, 1 month and 6 months after…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Frailty","Plasma Exchange","5% human albumin","Intravenous immunoglobulin (IVIG)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: plasma exchange.","quality_checked_at":"2026-09-25T06:20:05.499352+00:00","duplicate_cluster_key":"id:nct07836127","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-09-24 to 2028-11-14","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:04.695Z","intervention":["Plasma Exchange","5% human albumin","Intravenous immunoglobulin (IVIG)"],"participants":34,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Efficacy rate of frailty intervention at 1 month after the last treatment — 1 month after the last treatment","Efficacy rate of frailty intervention assessed by FRAIL Scale — Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24…","Strand specificity of frailty-related cfDNA and therapeutic response to plasma exchange — Baseline, 1 month and 6 month…","Clonal hematopoiesis gene mutation dynamics and correlation with frailty — Baseline, 4 week,24 week, 28 week, and 32 we…","BCR clonotype characteristics — Baseline, 1 month and 6 months after the last treatment","BCR V/J gene usage bias — Baseline, 1 month and 6 months after the last treatment","BCR diversity index — Baseline, 1 month and 6 months after the last treatment","Frequency of senescence-associated antigen-specific B cell clones — Baseline, 1 month and 6 months after the last treat…","TCR clonotype characteristics — Baseline, 1 month and 6 months after the last treatment","TCR diversity index — Baseline, 1 month and 6 months after the last treatment","TCR V/J gene usage bias — Baseline, 1 month and 6 months after the last treatment","Frequency of senescence-associated antigen-specific T cell clones — Baseline, 1 month and 6 months after the last treat…","Between-group differences in frailty scale score: ALB group vs ALB+IVIg group — Baseline, 4 week, 8 week, 12 week, 16 w…","Baseline changes of serum ALB modification at 1 month after last treatment — 1 month after the last treatment","Changes from baseline in senescence-related indicators at 1 month after last treatment — 1 month after the last treatme…","Changes from baseline in Tilburg Frailty Indicator (TFI) scores — Baseline, 4 week, 8 week, 12 week, 16 week, 20 week,…","Changes from baseline in Fried Frailty Phenotype Scale scores — Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24…","Changes from baseline in physical and mental health questionnaire scores — Baseline, 4 week, 8 week, 12 week, 16 week,…","Short Physical Performance Battery (SPPB) score — Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week…","Changes in gene mutation frequency and its correlation with immune cell subsets — Baseline, 1 month and 6 months after…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}},{"topic_slug":"plasma-exchange","is_published":true,"match_reasons":["Title contains controlled term: plasma exchange.","Abstract contains controlled term: plasma exchange.","Source terminology contains: plasma exchange.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Plasma exchange","slug":"plasma-exchange"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/20018","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}