Status:
UNKNOWN
The Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
Lead Sponsor:
Shanghai Cell Therapy Group Co.,Ltd
Conditions:
Postoperative Prevention of Tumor
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
The main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral NMN combined with DC cells injection in patients after tumor surgery, and evaluate the biological age of a...
Eligibility Criteria
Inclusion
- 1\. 18-80 years old, weight ≥ 40kg.
- 2\. Patients with malignant solid tumors diagnosed by histology or cytology, who underwent radical resection and completed standard postoperative adjuvant therapy.
- 3\. Estimated survival time ≥ 6 months.
- 4\. ECOG score 0-1.
- 5\. Adequate venous channels, there is no contraindication for peripheral blood monocyte collection.
- 6\. Good function of organs and bone marrow.
Exclusion
- 1\. Diabetes.
- 2\. Premenopausal or menopause \<1 year.
- 3\. Persons who have received hormone replacement therapy within the past 6 months.
- 4\. Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
- 5\. Unstable weight (\>3% change during the last 2 months before entering the study).
- 6\. Significant organ system dysfunction or disease.
- 7\. Polycystic ovary syndrome.
- 8\. Major psychiatric illness.
- 9\. Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study.
- 10\. Metal implants.
- 11\. Persons who consume \>14 units of alcohol per week.
- 12\. Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06036355
Start Date
September 30 2023
End Date
December 30 2024
Last Update
September 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Mengchao Cancer Hospital
Shanghai, Shanghai Municipality, China, 200240