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
|Condition or disease||Intervention/treatment||Phase|
|Aging Well Regenerative Medicine||Biological: human Mesenchymal Stem Cell (MSC) infusion therapy||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, Unblinded, non-randomized|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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
- Fasting lipid profile [ Time Frame: 1 year ]Fasting lipid profile will be assessed pre and post-infusion
- Change in Hormonal Profile [ Time Frame: 1 year ]FSH, LH, Estradiol, Progesterone, Testosterone Levels assessed pre and post-infusion
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
|Contact: Lucas TW Luk, MDfirstname.lastname@example.org|
|Contact: WeeKiat Tan, PhDemail@example.com|
|Landmark Medical Centre Sdn Bhd|
|Johor Bahru, Johor Darul Takzim, Malaysia, 80000|
|Contact: Dr Lucas Luk, MD +6072783333 firstname.lastname@example.org|
|Contact: Nelling Ong +6072783333 email@example.com|
|Principal Investigator: Dr Lucas Luk, MB BCh BAO (MD)|