MSC Infusion for Anti-aging and Regenerative Therapy
REGEN
Human Mesenchymal Stem Cell (hMSC) Infusion for Anti-Aging and REGENerative Therapy
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedStudy Start
First participant enrolled
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2022
CompletedNovember 22, 2019
November 1, 2019
12 months
November 19, 2019
November 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
Change in medication dosage (if any)
1 year
Other Outcomes (3)
Change from baseline, in plasma Glucose levels, over 52 weeks
1 year
Fasting lipid profile
1 year
Change in Hormonal Profile
1 year
Study Arms (1)
Treatment Population
EXPERIMENTAL100 million human MSCs in 200mls of normal saline, intravenously, once-off, over 1-2hours
Interventions
Subjects will be infused with 100million human MSCs
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- Patients who are currently participating in another clinical study involving experimenting drugs and/or medical equipment.
- Pregnant or Breastfeeding
- Patients who are unable to perform the tests and assessments needed for the study
- Patients who do not agree to participate in the study.
- Patients with pre-morbid medical conditions, who have recently had alterations in their treatment regime (\<6 months).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Landmark Medical Centre Sdn Bhdlead
- CytoMed Therapeutics Pte Ltdcollaborator
Study Sites (1)
Landmark Medical Centre Sdn Bhd
Johor Bahru, Johor Darul Takzim, 80000, Malaysia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Consultant Obstetrician & Gynaecologist
Study Record Dates
First Submitted
November 19, 2019
First Posted
November 22, 2019
Study Start
April 15, 2020
Primary Completion
April 14, 2021
Study Completion
April 14, 2022
Last Updated
November 22, 2019
Record last verified: 2019-11