Thymus Regeneration Therapy for Age-Related Immune Decline
(TRIIM-X Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment designed to regenerate the thymus, a part of the immune system that weakens with age. By combining medications such as DHEA (a hormone supplement), Metformin (a diabetes medication), and Recombinant Human Growth Hormone (Somatropin), the trial aims to slow or reverse aging effects on the immune system. This approach could help prevent issues like frailty, cancer, heart disease, diabetes, dementia, and infections such as flu and COVID-19. It suits individuals aged 40 to 80 who can commit to a 12-month study and do not have major health issues like certain heart conditions or diabetes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in immune health.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are on certain treatments like chronic glucocorticoid therapy or androgen supplementation with high testosterone levels. It's best to discuss your current medications with the trial team to see if they affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments tested in the TRIIM-X trial have been safe in previous studies and uses. Here's a breakdown of each part:
1. **Recombinant Human Growth Hormone (Somatropin):** The FDA has approved this hormone for treating adults with growth hormone deficiency, confirming its safety for that use. It has been used in older adults without major safety concerns and may help regenerate the thymus, a part of the immune system.
2. **Metformin:** This medication is well-known for treating type 2 diabetes. Research suggests it can also address age-related issues, such as a weakening immune system. Studies have found that metformin is generally safe and well-tolerated, even when used for other conditions.
3. **DHEA (Dehydroepiandrosterone):** This hormone decreases with age. Some studies suggest it may improve bone health and lower the risk of age-related diseases. Previous trials have not shown major safety concerns with DHEA.
Overall, these treatments have been studied and used for other conditions, demonstrating good safety records.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Thymus Regeneration Therapy for age-related immune decline because it combines DHEA, Metformin, and Recombinant Human Growth Hormone (Somatropin) to potentially rejuvenate the thymus gland, a key player in immune function. Unlike traditional treatments that might focus solely on symptom management, this approach targets the root cause of immune decline by encouraging the regeneration of thymic tissue. Additionally, the use of Somatropin is particularly intriguing, as it may directly stimulate thymus growth, something current treatments do not address. This multi-faceted approach holds promise for not only slowing down immune aging but possibly reversing it, setting it apart from existing options.
What evidence suggests that this trial's treatments could be effective for age-related immune decline?
Research has shown that using DHEA, metformin, and human growth hormone together may help regenerate the thymus, a crucial component of a healthy immune system. In this trial, participants in the TRIIM Treatment arm will receive this combination. Studies have found that these treatments can slow aging-related genetic changes and enhance immune system function. Metformin, for instance, can prevent thymus breakdown by boosting cell energy. DHEA is linked to better immune responses and may address age-related health issues. Growth hormone treatments have increased the production of certain immune cells by improving thymus function. Earlier research combining these treatments demonstrated significant improvements in immune health markers.45678
Are You a Good Fit for This Trial?
The TRIIM-X trial is for men and women aged 40 to 80, from any ethnicity, who can commit to a year-long study. It's not suitable for smokers, those with growth hormone deficiencies or high cancer risks, people on certain medications like steroids or HRT, anyone with serious heart conditions or uncontrolled diabetes, and premenopausal women.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a personalized combination treatment regimen for thymus regeneration, including recombinant human growth hormone, metformin, and DHEA
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DHEA
- Metformin
- Recombinant Human Growth Hormone (Somatropin)
DHEA is already approved in United States, European Union, Canada for the following indications:
- Adrenal insufficiency
- Hypogonadism
- Menopause symptoms
- Anti-aging (off-label)
- Bodybuilding (off-label)
- Vulvar and vaginal atrophy
- Adrenal insufficiency
- Hypogonadism
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intervene Immune, Inc.
Lead Sponsor