Personalized treatment for thymus regeneration and immune system restoration
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
This study is testing a personalized treatment plan using a mix of medications to see if it can help older adults regenerate their thymus and improve their immune system health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Intervene Immune, Inc. Industry-sponsored |
| Locations | 1 site (Torrance, California) |
| Trial ID | NCT04375657 on ClinicalTrials.gov |
What this trial studies
The TRIIM-X trial is an expanded pilot clinical study designed to evaluate a personalized combination treatment regimen aimed at regenerating the thymus, a crucial component of the immune system that deteriorates with age. This study will assess biomarkers related to epigenetic aging and immunosenescence, while also monitoring established clinical measures and risk factors for various age-related diseases. Participants will receive a combination of recombinant human growth hormone, metformin, and DHEA, tailored to their individual needs, similar to the previous TRIIM trial that showed promising results. The goal is to prevent or reverse aspects of aging and improve overall health outcomes in older adults.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 40 to 80 who are able to commit to a 12-month study and provide informed consent.
Not a fit: Patients with malignancies, significant cardiovascular disease, or those who are premenopausal or on hormone replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance immune function and overall health in aging individuals, potentially reducing the risk of age-related diseases.
How similar studies have performed: Previous studies, such as the earlier TRIIM trial at Stanford, have shown strong statistical significance with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Torrance, California
- Intervene Immune — Torrance, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.