Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CytoMed Therapeutics Pte Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Population | Experimental | 100 million human MSCs in 200mls of normal saline, intravenously, once-off, over 1-2hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human Mesenchymal Stem Cell (MSC) infusion therapy | Biological | Subjects will be infused with 100million human MSCs |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate number of Participants with Treatment-Related Adverse Events | 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. | 1 year |
| Improvement in General Well-Being, as assessed by our 'Quality of Life' Questionnaire, adapted from SF36. | 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. | 1 year |
| Change in inflammatory marker levels | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication dosage (if any) | IF patients with chronic medical conditions such as hypertension are on medication, patients will be assessed if hMSC infusion results in any change in required medication dosage | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline, in plasma Glucose levels, over 52 weeks | fasting glucose levels and HbA1c Levels will be assessed pre and post-infusion | 1 year |
| Fasting lipid profile | Fasting lipid profile will be assessed pre and post-infusion |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucas TW Luk, MD | Contact | +6072783333 | drlucas@landmarkmedical.com.my | |
| WeeKiat Tan, PhD | Contact | weekiattan@cytomed.sg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landmark Medical Centre Sdn Bhd | Johor Bahru | Johor Darul Takzim | 80000 | Malaysia |
Not provided
Prospective, Unblinded, non-randomized
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Change in Hormonal Profile | FSH, LH, Estradiol, Progesterone, Testosterone Levels assessed pre and post-infusion | 1 year |