MSC Infusion for Anti-aging and Regenerative Therapy

Aging Well Clinical Trial

— REGEN  

Official title:

Human Mesenchymal Stem Cell (hMSC) Infusion for Anti-Aging and REGENerative Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04174898
• Other study ID #: Protocol LMC-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 15, 2020
• Est. completion date: April 14, 2022

Study information

• Verified date: November 2019
• Source: Landmark Medical Centre Sdn Bhd
• Contact: Lucas TW Luk, MD
• Phone: +6072783333
• Email: drlucas[@]landmarkmedical.com.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aging Well
• Regenerative Medicine

Intervention

Biological:
• human Mesenchymal Stem Cell (MSC) infusion therapy
Subjects will be infused with 100million human MSCs

Locations

Country	Name	City	State
Malaysia	Landmark Medical Centre Sdn Bhd	Johor Bahru	Johor Darul Takzim

Sponsors (2)

Lead Sponsor	Collaborator
Landmark Medical Centre Sdn Bhd	CytoMed Therapeutics Pte Ltd

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Fasting lipid profile	Fasting lipid profile will be assessed pre and post-infusion	1 year
Other	Change in Hormonal Profile	FSH, LH, Estradiol, Progesterone, Testosterone Levels assessed pre and post-infusion	1 year
Primary	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
Primary	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
Primary	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	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