Status:
RECRUITING
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
Lead Sponsor:
Intervene Immune, Inc.
Conditions:
Epigenetic Aging
Immunosenescence
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04375657
Start Date
November 23 2020
End Date
December 1 2025
Last Update
May 7 2025
Active Locations (1)
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1
Intervene Immune
Torrance, California, United States, 90502