Thymus Nuclear Extract for Healthy Individuals

Overseen By Bisma Sharif, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Standard Process Inc.

Disqualifiers: Pregnancy, Diabetes, Hypertension, Neurological disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you must agree to follow any restrictions on treatments as listed by the study, so it's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment Bovine Thymus Nuclear Extract for healthy individuals?

Research shows that thymus extracts can boost immune responses. For example, in elderly patients, a thymic extract improved immune memory, and in chickens, it enhanced immune protection and body weight gain when combined with vaccination. ^{1 2 3 4 5}

Is Bovine Thymus Nuclear Extract safe for humans?

Research indicates that Bovine Thymus Nuclear Extract does not show cytotoxicity (cell damage) in human cells, suggesting it is generally safe. However, more specific human safety data is needed. ^{1 6 7 8 9}

How does the treatment Bovine Thymus Nuclear Extract differ from other treatments?

Bovine Thymus Nuclear Extract is unique because it is derived from the thymus gland of cows and is used to potentially enhance immune function by promoting the maturation of immune cells. Unlike standard treatments, it is specifically focused on boosting the immune system, which may be beneficial for conditions related to immune deficiencies or chronic immune-mediated diseases. ^{1 9 10 11 12}

What is the purpose of this trial?

The goal of this trial is to find out if Thymus Nuclear Extract is safe and well-tolerated in healthy men and women by testing three different dose levels and comparing the results to a placebo.

Research Team

Bassem F. El-Khodor, PHD

Principal Investigator

Standard Process Inc.

Eligibility Criteria

This trial is for healthy men and women who are interested in testing the safety of a Thymus Nuclear Extract at three different dose levels. Specific eligibility criteria details were not provided, so general good health is assumed to be required.

Inclusion Criteria

In good general health as deemed by the investigator and able to consume the study product

Have a body mass index (BMI) range of 18.5 - 29.9 kg/m2 (inclusive)

Agree to use acceptable contraceptive methods

Exclusion Criteria

I have been treated or hospitalized for a mental health issue in the past year.

I haven't had major surgery in the last 3 months and don't plan any during the study.

I have received an organ transplant or tissue from a donor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Thymus Nuclear Extract or placebo for safety and tolerability assessment

12 weeks

Regular visits for safety assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Follow-up visits for additional assessments

Treatment Details

Interventions

• Bovine Thymus Nuclear Extract

Trial Overview The study is evaluating the safety and tolerability of a Bovine Thymus Nuclear Extract by administering three different doses (TPG1, TPG2, TPG3) compared to a placebo in a randomized, double-blind setup where neither participants nor researchers know who gets what treatment.

Participant Groups

Group I: TPG3 Active Control 1 Intervention

Thymus Nuclear Extract Dose 3

Group II: TPG1 Active Control 1 Intervention

Thymus Nuclear Extract Dose 1

Group III: TPG2 Active Control 1 Intervention

Thymus Nuclear Extract Dose 2

Group IV: PL Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Standard Process Inc.

Lead Sponsor

Trials

15

Recruited

680+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Findings from Research

Bovine thymic extracts A, B, and C were found to increase the longevity of immunodeficient nude mice, but they did not successfully mature T lymphocytes or restore the ability to reject heart transplants.

Preincubating bone marrow cells with thymic extract B improved the number of antibody-producing cells in irradiated mice, suggesting that while thymic extracts can enhance certain immune responses, complete T lymphocyte maturation requires additional factors beyond just thymic extract stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of reconstitution of immunodeficient mice by partially purified thymic extracts. Splitter, GA., McGuire, TC., Davis, WC.[2006]

In a study involving 24 elderly patients, a thymic calf extract (LEUCOTROFINA) significantly improved lymphocytic memory against certain antigens in patients aged 65 to 75, with positive responses increasing from 47% to 84.6%.

No significant improvement was observed in patients over 75 years old, indicating that the efficacy of thymic extract therapy may be age-dependent, particularly benefiting younger elderly individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Changes induced by calf thymus extract on cell-mediated immunity, evaluated by intradermal tests, in the elderly]. Di Feliciantonio, R., Trentini, M.[2006]

Oral administration of crude thymus extract in one-day-old chicks significantly enhanced immune response, leading to increased total protein, albumin, globulin, and body weight gain, as well as a higher lymphocyte count over four weeks.

Chicks treated with thymus extract and vaccinated against infectious bursal disease virus (IBDV) achieved 100% protection from the virus, compared to 80% protection in the vaccinated group without thymus treatment, indicating that thymus extract boosts vaccine effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of thymus extract on immunologic reactivity of chicken vaccinated with infectious bursal disease virus. Abdel-Fattah, AF., Mohamed, EH., Mohamed, ES., et al.[2019]

In a study of 31 heart transplant recipients, early administration of thymoglobulin was found to protect against cardiocyte hypertrophy, which is an enlargement of heart cell nuclei, compared to a control group.

The ATG group (those who received thymoglobulin) showed stable and lower nuclear geometric parameters over time, indicating less myocardial hypertrophy and reduced graft ischemic damage compared to those who did not receive thymoglobulin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thymoglobulin administered early after heart transplantation reduces early myocardial hypertrophy assessed by morphometric studies. Nozynski, J., Zakliczynski, M., Zembala-Nozynska, E., et al.[2022]

In a study involving 7 pairs of MHC-mismatched canines, donor thymic tissue was transplanted to induce tolerance in kidney allografts, but no tolerance was achieved despite normal thymic development observed at 90 days post-transplant.

While hyperacute rejection was absent, allografts experienced acute cell-mediated rejection after 3 months, indicating that further research is needed to explore the potential of thymic transplantation combined with immunosuppressants or using MHC-matched canines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can thymic tissue induce tolerance to kidney allografts? Shakeri, S., Aminsharifi, A., Khezri, A., et al.[2007]

Bovine thymus tissue preparations significantly inhibit DNA synthesis in stimulated human lymphocytes and other immune cells, demonstrating a strong dose-dependent effect.

The inhibitory effect is specific to proliferating lymphocytes, as no suppression was observed in non-immune cells like HeLa cells and human fibroblasts, indicating a targeted mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thymus derived inhibitor of lymphocyte proliferation. I. Isolation and assessment of tissue specificity. Rijke, EO., Ballieux, RE.[2019]

A toxicological risk assessment of traditional herbal medicinal products containing Thymi herba from Polish pharmacies showed that cadmium (Cd) impurities were within safe limits, with daily exposure levels below 40 ng/day.

The estimated daily exposure to Cd from these herbal products meets the ICH Q3D (R1) guideline of 5.0 µg/day, indicating that these products do not pose a health risk to consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cadmium impurities in traditional herbal medicinal products with Thymi herba available in Polish pharmacies - short communication: the level of Cd impurities and comprehensive toxicological risk assessment. Jurowski, K., Krośniak, M.[2023]

Microwave-assisted extraction (MAE) of thyme yielded the highest concentration of thymol and beneficial compounds, making it the most effective method for obtaining a thymol-enriched extract, which showed strong antioxidant properties.

The thyme extract obtained through MAE (TMAE) significantly inhibited platelet aggregation in human plasma without causing cytotoxic effects, suggesting its potential use in preventing cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thymol-enriched extract from Thymus vulgaris L leaves: Green extraction processes and antiaggregant effects on human platelets. Adhar, M., HadjKacem, B., Périno-Issartier, S., et al.[2022]

Calf thymus extract (CTE) was significantly more effective than rabbit thymus extract (RTE) in detecting antibodies to extractable nuclear antigens (ENA), identifying 90% more ENA positive patients and 155% more lines.

CTE also demonstrated superior stability at -80 degrees Celsius and provided clearer precipitin lines, allowing for better differentiation of specific antibodies like Sm and RNP compared to RTE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of antibodies to extractable nuclear antigens using calf thymus and rabbit thymus. A comparative study of 1000 consecutive anti-nuclear antibody positive patients. Collins, RJ., Neil, JC., Druery, LN., et al.[2019]

The semipurified calf thymus extract, TFX, has been evaluated in over 1000 patients with various immune-related diseases, showing significant biological activity similar to thymic hormones.

Long-term immunotherapy with TFX led to symptom improvement and normalization of immune parameters in many patients, suggesting it could enhance treatment protocols for those with immunodeficiencies or chronic immune-mediated conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic application of calf thymus extract (TFX). Skotnicki, AB.[2019]

Thymus extract (TFX) administered to 35 patients with alimentary tract malignancies showed biological activity in humans, enhancing cell-mediated immunity.

TFX treatment may help restore immune function in patients who have undergone surgery for cancer, suggesting its potential as an immunotherapeutic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial observations on the administration of thymus extract (TFX) in patients with alimentary tract neoplasms. Cybulski, L., Turowski, G., Politowski, M., et al.[2004]

Calf thymus extract (TFX) enhances the mobility of normal human T lymphocytes and granulocytes in vitro, indicating a potential role in immune response modulation.

TFX acts as a strong chemotactic factor, outperforming both normal human serum (NHS) and casein, suggesting its effectiveness in guiding immune cells to sites of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of calf thymus extract (TFX) on human T lymphocyte and neutrophil mobility and chemotactic response in vitro. Smogorzewska, EM., Korczyńska, M., Gołebiowska, H.[2014]

References

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

Evaluation of reconstitution of immunodeficient mice by partially purified thymic extracts. [2006]

2. Italy pubmed.ncbi.nlm.nih.gov

[Changes induced by calf thymus extract on cell-mediated immunity, evaluated by intradermal tests, in the elderly]. [2006]

3. Japan pubmed.ncbi.nlm.nih.gov

Effect of thymus extract on immunologic reactivity of chicken vaccinated with infectious bursal disease virus. [2019]

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

Thymoglobulin administered early after heart transplantation reduces early myocardial hypertrophy assessed by morphometric studies. [2022]

5. Iran pubmed.ncbi.nlm.nih.gov

Can thymic tissue induce tolerance to kidney allografts? [2007]

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

Thymus derived inhibitor of lymphocyte proliferation. I. Isolation and assessment of tissue specificity. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Cadmium impurities in traditional herbal medicinal products with Thymi herba available in Polish pharmacies - short communication: the level of Cd impurities and comprehensive toxicological risk assessment. [2023]

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

Thymol-enriched extract from Thymus vulgaris L leaves: Green extraction processes and antiaggregant effects on human platelets. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Detection of antibodies to extractable nuclear antigens using calf thymus and rabbit thymus. A comparative study of 1000 consecutive anti-nuclear antibody positive patients. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Therapeutic application of calf thymus extract (TFX). [2019]

11. Poland pubmed.ncbi.nlm.nih.gov

Initial observations on the administration of thymus extract (TFX) in patients with alimentary tract neoplasms. [2004]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of calf thymus extract (TFX) on human T lymphocyte and neutrophil mobility and chemotactic response in vitro. [2014]