Human Mesenchymal Stem Cell (hMSC) Infusion for Anti-Aging and REGENerative Therapy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Aging Well
- Sponsor
- Landmark Medical Centre Sdn Bhd
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in inflammatory marker levels
- Last Updated
- 6 years ago
Overview
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.
Investigators
Dr Lucas Luk Tien Wee
Director, Consultant Obstetrician & Gynaecologist
Landmark Medical Centre Sdn Bhd
Eligibility Criteria
Inclusion Criteria
- •All patients \>18yrs old, who are able to read, write and understand Informed Consent form, regarding the experimental nature of this therapy.
- •All Healthy Subjects are eligible for this study
- •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
- •Uncontrolled blood pressure at the time of enrollment: systolic pressure \>160 mmHg and/or diastolic blood pressure \> 100 mmHg.
- •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
- •Severe heart disease (NYHA 3/4 or congestive heart failure)
- •Severe liver disease (liver enzymes \>2x baseline, or evidence of coagulopathy)
- •Evidence of ketoacidosis at the time of selection.
- •Evidence of ongoing or frequent hypoglycemia.
- •Severe infection at time of selection
- •Infected with hepatitis B virus or hepatitis C or tuberculosis.
- •Serious allergic constitution
- •Neoplasm detected before/during screening or raised tumour markers CA125 (Females), CA15.3 (Females), CEA, CA19.9, Alpha Fetoprotein (AFP), PSA (Males)
Outcomes
Primary Outcomes
Change in inflammatory marker levels
Time Frame: 1 year
IL-6, TNF alpha and CRP have been widely studied as markers of aging. These will be assessed in our trial subjects to ascertain if hMSC infusion results in any reduction in these inflammatory markers
To evaluate number of Participants with Treatment-Related Adverse Events
Time Frame: 1 year
The safety of both Adipose derived and Umbilical Cord derived MSCs (both of Autologous and Allogenic sources) will be studied in clinical trial subjects. Adverse events will be documented and patients will be followed up over a period of 1 year post-infusion, to assess their well being. Clinical assessments and biochemical tests will be performed over the study period.
Improvement in General Well-Being, as assessed by our 'Quality of Life' Questionnaire, adapted from SF36.
Time Frame: 1 year
A 'Quality of Life' Questionnaire will be filled by Trial Participants pre and post-infusion therapy. This questionnaire has been adapted from SF36 and scales of 1-5 are used to grade an individual's well being - A score of 1 being worse and 5 meaning a better outcome.
Secondary Outcomes
- Change in medication dosage (if any)(1 year)