Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial

Launched by INTERVENE IMMUNE, INC. · May 3, 2020

Keywords

ClinConnect Summary

The TRIIM-X trial is a clinical study designed to explore a personalized treatment plan aimed at helping the thymus, an important part of our immune system that weakens as we age. By regenerating the thymus, the researchers hope to improve the immune system's function and potentially slow down some effects of aging, such as frailty, cancer, heart disease, diabetes, and even diseases like COVID-19. The study will use a combination of medications, including a growth hormone and other approved treatments, tailored to individual needs, with the goal of gathering essential information for future studies.

To participate in this trial, individuals must be between 40 and 80 years old and able to commit to a 12-month study period. Both men and women of all ethnicities are encouraged to join, as long as they meet specific health criteria. Participants can expect regular check-ups and assessments to monitor their health and the effects of the treatment. It's important to note that individuals with certain medical conditions or those taking specific medications may not be eligible. Overall, this trial aims to provide valuable insights into how we can better support healthy aging through personalized medicine.

Gender

ALL

Eligibility criteria

• 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