Thymus Regeneration Therapy for Age-Related Immune Decline

(TRIIM-X Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Intervene Immune, Inc.

Must be taking: Somatropin, Metformin, DHEA

Must not be taking: Glucocorticoids, Carbonic anhydrase inhibitors

Disqualifiers: Cancer, Cardiovascular disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

85 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a personalized mix of medicines to help regenerate the thymus, an important part of the immune system that weakens with age. The treatment includes a growth hormone, a diabetes drug (metformin), and a hormone supplement (DHEA). It aims to strengthen the immune system and possibly slow down aging in elderly people.

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.

What evidence supports the effectiveness of the treatment for thymus regeneration therapy in age-related immune decline?

Research shows that growth hormone (GH) can enhance thymic function and increase T-cell production, which may help improve immune recovery in adults, including those with age-related immune decline. This suggests that GH, a component of the treatment, could be effective in regenerating the thymus and boosting the immune system. ^{1 2 3 4 5}

Is thymus regeneration therapy using growth hormone safe for humans?

Research shows that growth hormone therapy can increase thymic mass and improve immune function in humans, such as in HIV-infected adults, without significant safety concerns reported. However, there is a case of thymic hyperplasia (enlargement of the thymus) in a child treated with growth hormone, indicating that monitoring may be necessary. ^{2 3 6 7 8}

How is the Thymus Regeneration Therapy for Age-Related Immune Decline different from other treatments?

This treatment is unique because it combines DHEA, Metformin, and Recombinant Human Growth Hormone to target thymus regeneration, which is not a standard approach for age-related immune decline. These components are known for their roles in hormone regulation and metabolism, potentially offering a novel way to rejuvenate the thymus and improve immune function in older adults. ^{3 4 7 9 10}

Eligibility Criteria

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

Able to provide informed consent

I am between 40 and 80 years old.

Able to participate in 12-month study

Exclusion Criteria

I am a postmenopausal woman currently on hormone replacement therapy.

I am a woman who has not gone through menopause.

I have a slow heart rate, high blood pressure, severe chest pain, or other serious heart conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized combination treatment regimen for thymus regeneration, including recombinant human growth hormone, metformin, and DHEA

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DHEA
• Metformin
• Recombinant Human Growth Hormone (Somatropin)

Trial Overview This trial tests a personalized treatment aiming to regenerate the thymus and improve immune function in older adults. It involves recombinant human growth hormone (somatropin), metformin, DHEA doses based on prior trials' safety data. The goal is to refine this regimen for broader use and validate biomarkers related to aging prevention.

Participant Groups

Group I: TRIIM Treatment Experimental Treatment 1 Intervention

Group II: Active Control Active Control 1 Intervention

DHEA is already approved in United States, European Union, Canada for the following indications:

Approved in United States as DHEA for:

• Adrenal insufficiency
• Hypogonadism
• Menopause symptoms
• Anti-aging (off-label)
• Bodybuilding (off-label)

Approved in European Union as Prasterone for:

• Vulvar and vaginal atrophy

Approved in Canada as DHEA for:

• Adrenal insufficiency
• Hypogonadism

Who Is Running the Clinical Trial?

Intervene Immune, Inc.

Lead Sponsor

Trials

1

Recruited

90+

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of growth hormone in enhancing thymic regrowth and T-cell reconstitution. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Growth hormone enhances thymic function in HIV-1-infected adults. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of insulin-like growth factor administration and bone marrow transplantation on thymopoiesis in aged mice. [2007]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical strategies to enhance thymic recovery after allogeneic hematopoietic stem cell transplantation. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Reappearance of the thymus in old rats after orchidectomy: inhibition of regeneration by testosterone. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Improved thymic index, density and output in HIV-infected patients following low-dose growth hormone therapy: a placebo controlled study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of growth hormone on the adult canine thymus. [2018]

8. Scotland pubmed.ncbi.nlm.nih.gov

Thymic hyperplasia in a child treated with growth hormone. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Immune Reconstitution after Allogeneic Hematopoietic Stem Cell Transplantation: Time To T Up the Thymus. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Restored Thymic Output after Androgen Blockade Participates in Antitumor Immunity. [2023]