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| Name | Class |
|---|---|
| CIRCULATE, Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPE Monthly | Active Comparator | will receive 6 monthly TPE procedures (TOTAL 6 treatments) |
|
| TPE Bimonthly | Active Comparator | 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) |
|
| TPE Bimonthly with IVIG | Active Comparator | 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) |
|
| Sham | Sham Comparator | Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham | Device | The patient's blood will not circulate through the apheresis machine. The patient will receive approximately 250 cc of normal saline during each sham pheresis procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and unanticipated events total for TPE safety | The primary objective is to assure the safety of long term TPE | through study completion, an average of 1 year |
| Rate of change to blood epigenetic clock from TPE | The objective is to compare the rate of change to the blood epigenetic clock from TPE. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hand grip strength | The objective is to compare changes in hand grip strength from TPE | after study completion, an average of 2 years |
| Change in time up and go test | The objective is to compare changes in the time up and go test from TPE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dobri Kiprov, MD | Global Apheresis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Apheresis | Mill Valley | California | 94941 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40424097 | Derived | Fuentealba M, Kiprov D, Schneider K, Mu WC, Kumaar PA, Kasler H, Burton JB, Watson M, Halaweh H, King CD, Yuksel ZS, Roska-Pamaong C, Schilling B, Verdin E, Furman D. Multi-Omics Analysis Reveals Biomarkers That Contribute to Biological Age Rejuvenation in Response to Single-Blinded Randomized Placebo-Controlled Therapeutic Plasma Exchange. Aging Cell. 2025 Aug;24(8):e70103. doi: 10.1111/acel.70103. Epub 2025 May 27. |
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| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
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| Therapeutic Plasma Exchange | Device | Blood is withdrawn from a peripheral or central vein into the blood cell separator which separates the whole blood into plasma and cell components. The plasma is removed and the blood cells are returned to the patient along with replacement fluids, most commonly 5% human albumin in normal saline. |
|
| IVIG | Drug | Intravenous Immunoglobulin |
|
| after study completion, an average of 2 years |
| Change in balance time | The objective is to compare changes in balance time from TPE | after study completion, an average of 2 years |
| Change in short-form health survey score | The objective is to compare changes in short-form health survey scores from TPE, with higher scores being better | after study completion, an average of 2 years |
| D001781 |
| Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |