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

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

Study Overview

• Status: Unknown
• Conditions: Aging Well; Regenerative Medicine
• Intervention / Treatment: Biological: human Mesenchymal Stem Cell (MSC) infusion therapy

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Malaysia
  • Johor Darul Takzim
    • Johor Bahru, Johor Darul Takzim, Malaysia, 80000
      • Landmark Medical Centre Sdn Bhd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	1 year
Change in Hormonal Profile	FSH, LH, Estradiol, Progesterone, Testosterone Levels assessed pre and post-infusion	1 year

Collaborators and Investigators

• Sponsor: Landmark Medical Centre Sdn Bhd
• Collaborators: CytoMed Therapeutics Pte Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2020
• Primary Completion (Anticipated): April 14, 2021
• Study Completion (Anticipated): April 14, 2022

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Regenerative Medicine; human Mesenchymal Stem Cells (hMSC); Anti-Aging; Adipose Derived MSCs; Umbilical Cord Derived MSCs; Autologous hMSC; Allogenic hMSC
• Other Study ID Numbers: Protocol LMC-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No