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โ† Trials
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Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial

RecruitingPhase 2Ages 40 Years - 80 YearsAllIntervene Immune, Inc.
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In plain words

What the trial is, and whether it could suit you

The TRIIM-X trial is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. The thymus is a part of the immune system that declines markedly with age, and regenerating it may prevent or reverse key aspects of immunosenescence (immune system aging) and potentially prevent or reverse key parts of the aging process more generally. The study will evaluate biomarkers for epigenetic aging and immunosenescence, as well as evaluate established clinical measures and risk factors for prevention of physical frailty, cancer, cardiovascular disease, diabetes, dementia, and also infectious diseases, including flu and COVID-19. The study uses multiple agents in combination with personalized doses of recombinant human growth hormone (somatropin), metformin, and DHEA, in a similar manner to how the combination treatment was applied in th

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female volunteers * Aged 40 to 80 years, inclusive * All ethnicities * Able to participate in 12-month study * Able to provide informed consent Exclusion Criteria: * Malignancies or high risk of malignancy, as suggested by familial risk or personal medical history * Premenopausal women * Postmenopausal women on HRT * IGF-1 levels \< 90 ng/ml or \>300 ng/ml * Diagnosed or suspected growth hormone resistance * Known growth hormone deficiency based on stimulation testing * Pre-existing carpal tunnel syndrome * Significant arthritis/arthralgia/joint swelling * Bradycardia (\<55 bpm), significant hypertension (systolic \>160 mmHg, or diastolic \>90 mmHg) despite treatment, serious angina, or other serious cardiovascular disease or cardiovascular disease risk factors * Excessive skin growths (e.g., flat warts) without cryosurgical options * BMI of 35 or greater * PSA level above the age-adjusted normal range for reasons other than confirmed prostatitis * Testosterone levels above the upper limit of normal * Levels of C-reactive protein (CRP) above the upper limit of normal * Type 1 or pre-existing Type 2 diabetes * Uncorrected hypothyroidism * HIV infection * Allergy or other sensitivity to study medications * Other unstable medical conditions * Use of GH within the last 5 years * Participation in a clinical research trial within 30 days prior to enrollment * Use of chronic glucocorticoid therapy * Unwilling to discontinue androgen supplementation if testosterone levels are above the upper limit of normal * Ongoing treatment with carbonic anhydrase inhibitors * Ketogenic diet, calorie-restricted diet, or prolonged fasting, without willingness to discontinue these diets or adhere to an alternative diet during the study * Alcoholism or drug addiction * Smoking or unwillingness to quit smoking * Cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent
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What it tests

  • TRIIM Treatment
  • Active Control
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Where

1 site
Intervene Immune
Torrance, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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