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MSC Infusion for Anti-aging and Regenerative Therapy (REGEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04174898
Recruitment Status : Not yet recruiting
First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
CytoMed Therapeutics Pte Ltd
Information provided by (Responsible Party):
Dr Lucas Luk Tien Wee, Landmark Medical Centre Sdn Bhd

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

Condition or disease Intervention/treatment Phase
Aging Well Regenerative Medicine Biological: human Mesenchymal Stem Cell (MSC) infusion therapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, Unblinded, non-randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Human Mesenchymal Stem Cell (hMSC) Infusion for Anti-Aging and REGENerative Therapy
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : April 14, 2021
Estimated Study Completion Date : April 14, 2022

Arm Intervention/treatment
Experimental: Treatment Population
100 million human MSCs in 200mls of normal saline, intravenously, once-off, over 1-2hours
Biological: human Mesenchymal Stem Cell (MSC) infusion therapy
Subjects will be infused with 100million human MSCs




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. Change in medication dosage (if any) [ Time Frame: 1 year ]
    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


Other Outcome Measures:
  1. Change from baseline, in plasma Glucose levels, over 52 weeks [ Time Frame: 1 year ]
    fasting glucose levels and HbA1c Levels will be assessed pre and post-infusion

  2. Fasting lipid profile [ Time Frame: 1 year ]
    Fasting lipid profile will be assessed pre and post-infusion

  3. Change in Hormonal Profile [ Time Frame: 1 year ]
    FSH, LH, Estradiol, Progesterone, Testosterone Levels assessed pre and post-infusion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174898


Contacts
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Contact: Lucas TW Luk, MD +6072783333 drlucas@landmarkmedical.com.my
Contact: WeeKiat Tan, PhD weekiattan@cytomed.sg

Locations
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Malaysia
Landmark Medical Centre Sdn Bhd
Johor Bahru, Johor Darul Takzim, Malaysia, 80000
Contact: Dr Lucas Luk, MD    +6072783333    drlucas@landmarkmedical.com.my   
Contact: Nelling Ong    +6072783333    nellieong@landmarkmedical.com.my   
Principal Investigator: Dr Lucas Luk, MB BCh BAO (MD)         
Sponsors and Collaborators
Landmark Medical Centre Sdn Bhd
CytoMed Therapeutics Pte Ltd
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Responsible Party: Dr Lucas Luk Tien Wee, Director, Consultant Obstetrician & Gynaecologist, Landmark Medical Centre Sdn Bhd
ClinicalTrials.gov Identifier: NCT04174898    
Other Study ID Numbers: Protocol LMC-101
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Lucas Luk Tien Wee, Landmark Medical Centre Sdn Bhd:
human Mesenchymal Stem Cells (hMSC)
Anti-Aging
Regenerative Medicine
Adipose Derived MSCs
Umbilical Cord Derived MSCs
Autologous hMSC
Allogenic hMSC