MSC Infusion for Anti-aging and Regenerative Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2022-04-14

Brief Summary

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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

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Detailed Description

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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

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Aging Well Regenerative Medicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, Unblinded, non-randomized

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment Population

100 million human MSCs in 200mls of normal saline, intravenously, once-off, over 1-2hours

Group Type EXPERIMENTAL

human Mesenchymal Stem Cell (MSC) infusion therapy

Intervention Type BIOLOGICAL

Subjects will be infused with 100million human MSCs

Interventions

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human Mesenchymal Stem Cell (MSC) infusion therapy

Subjects will be infused with 100million human MSCs

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes