Aging WellPhase 1REGENNCT04174898
MSC Infusion for Anti-aging and Regenerative Therapy
A Phase 1 study testing human Mesenchymal Stem Cell (MSC) infusion therapy in people with Aging Well and Regenerative Medicine, run by Landmark Medical Centre Sdn Bhd at 1 site in Malaysia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Well, Regenerative Medicine
- What is being tested?
- human Mesenchymal Stem Cell (MSC) infusion therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Apr 2020to 14 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
WeeKiat Tan, PhD contact
Malaysia1 site
Landmark Medical Centre Sdn Bhd
Johor Bahru, Johor Darul Takzim, 80000
Dr Lucas Luk, MD, +6072783333, drlucas@landmarkmedical.com.my
Nelling Ong, +6072783333, nellieong@landmarkmedical.com.my
About this study
Official title: Human Mesenchymal Stem Cell (hMSC) Infusion for Anti-Aging and REGENerative Therapy
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
Read the 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.
- Conditions
- Aging Well, Regenerative Medicine
- Being tested
- human Mesenchymal Stem Cell (MSC) infusion therapy
- Keywords
- human Mesenchymal Stem Cells (hMSC), Anti-Aging, Regenerative Medicine, Adipose Derived MSCs, Umbilical Cord Derived MSCs, Autologous hMSC, Allogenic hMSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human Mesenchymal Stem Cell (MSC) infusion therapyBiological
Subjects will be infused with 100million human MSCs
| Study group | Role | What they receive |
|---|---|---|
| Treatment Population | Experimental | 100 million human MSCs in 200mls of normal saline, intravenously, once-off, over 1-2hours Receives: Biological: human Mesenchymal Stem Cell (MSC) infusion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start15 Apr 2020 (estimated)
- Primary completion14 Apr 2021 (estimated)
- Study completion14 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Unblinded, non-randomized
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Landmark Medical Centre Sdn Bhd
- Sponsor type
- University, hospital or other
- Collaborators
- CytoMed Therapeutics Pte Ltd
- Responsible party
- Principal investigator, Dr Lucas Luk Tien Wee, Landmark Medical Centre Sdn Bhd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174898
- Sponsor's protocol ID
- Protocol LMC-101
- Acronym
- REGEN
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Mesenchymal Stem Cell (hMSC) Infusion for Anti-Aging and REGENerative Therapy
- ClinicalTrials.gov ID
- NCT04174898
- Acronym / sponsor ID
- REGEN / Protocol LMC-101
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Landmark Medical Centre Sdn BhdUniversity, hospital or other
- Collaborators
- CytoMed Therapeutics Pte Ltd
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 14 Apr 2021 (estimated)
- Study completion
- 14 Apr 2022 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Unblinded, non-randomized
| Arm | Type | Receives |
|---|---|---|
| Treatment Population | Experimental | Biological: human Mesenchymal Stem Cell (MSC) infusion therapy100 million human MSCs in 200mls of normal saline, intravenously, once-off, over 1-2hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human Mesenchymal Stem Cell (MSC) infusion therapySubjects will be infused with 100million human MSCs | Biological | Treatment Population |
Primary outcome
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.
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
1 secondary outcome
Change in medication dosage (if any)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WeeKiat Tan, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human Mesenchymal Stem Cell (MSC) infusion therapy in people with Aging Well and Regenerative Medicine, run by Landmark Medical Centre Sdn Bhd at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas TW Luk, MD (+6072783333, drlucas@landmarkmedical.com.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate number of Participants with Treatment-Related Adverse Events (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.