Clinical trial NCT04174898: MSC Infusion for Anti-aging and Regenerative Therapy
Official title: Human Mesenchymal Stem Cell (hMSC) Infusion for Anti-Aging and REGENerative Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aging Well
Regenerative Medicine
Keywords: human Mesenchymal Stem Cells (hMSC)
Anti-Aging
Regenerative Medicine
Adipose Derived MSCs
Umbilical Cord Derived MSCs
Autologous hMSC
Allogenic hMSC
Lead sponsor: Landmark Medical Centre Sdn Bhd
Sponsor class: OTHER
Collaborators: name: CytoMed Therapeutics Pte Ltd
First posted: 2019-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Unblinded, non-randomized
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and efficacy of human Mesenchymal Stem Cell (hMSC) infusion therapy, in preserving general wellness and ameliorating or reversing the effects of aging in our study population

Detailed description: 100million human mesenchymal stem cells will be infused into study subjects. They will be followed up for both objective and subjective measures of 'anti-aging'. Biochemical markers such as male and female hormones and other parameters of well being will be measured. A questionnaire will also be filled pre and post infusion to ascertain one's well-being (Adapted from SF-36).

Source of MSCs - Autologous (Adipose tissue) or Allogenic (Adipose tissue or umbilical cord)

MSC production and storage will be performed in a GMP certified laboratory setting.

Eligibility criteria: Inclusion Criteria:

1. All patients \>18yrs old, who are able to read, write and understand Informed Consent form, regarding the experimental nature of this therapy.
2. All Healthy Subjects are eligible for this study
3. Subjects with stable pre-morbid medical conditions, not requiring changes to their current medical therapy for \>6 months prior to enrolling in this study, are eligible.

Exclusion Criteria:

1. Uncontrolled blood pressure at the time of enrollment: systolic pressure \>160 mmHg and/or diastolic blood pressure \> 100 mmHg.
2. Having evidence related to renal dysfunction: creatinine \> 1.5 mg/dl or (\>133 mmol/L) for men. creatinine \> 1.4 mg/dl or (\>124 mmol/L) for woman. eGRF \< 40 ml/ min Proteinuria \> 300 mg/day
3. Severe heart disease (NYHA 3/4 or congestive heart failure)
4. Severe liver disease (liver enzymes \>2x baseline, or evidence of coagulopathy)
5. Evidence of ketoacidosis at the time of selection.
6. Evidence of ongoing or frequent hypoglycemia.
7. Severe infection at time of selection
8. Infected with hepatitis B virus or hepatitis C or tuberculosis.
9. Serious allergic constitution
10. Neoplasm detected before/during screening or raised tumour markers CA125 (Females), CA15.3 (Females), CEA, CA19.9, Alpha Fetoprotein (AFP), PSA (Males)
11. Patients who are currently participating in another clinical study involving experimenting drugs and/or medical equipment.
12. Pregnant or Breastfeeding
13. Patients who are unable to perform the tests and assessments needed for the study
14. Patients who do not agree to participate in the study.
15. Patients with pre-morbid medical conditions, who have recently had alterations in their treatment regime (\<6 months).

Primary outcomes:
measure: To evaluate number of Participants with Treatment-Related Adverse Events
timeFrame: 1 year
measure: Improvement in General Well-Being, as assessed by our 'Quality of Life' Questionnaire, adapted from SF36.
timeFrame: 1 year
measure: Change in inflammatory marker levels
timeFrame: 1 year
Secondary outcomes:
measure: Change in medication dosage (if any)
timeFrame: 1 year
Other outcomes:
measure: Change from baseline, in plasma Glucose levels, over 52 weeks
timeFrame: 1 year
measure: Fasting lipid profile
timeFrame: 1 year
measure: Change in Hormonal Profile
timeFrame: 1 year
Locations:
city: Johor Bahru
country: Malaysia
facility: Landmark Medical Centre Sdn Bhd
state: Johor Darul Takzim
Study officials:
References: