AgingPhase 1NCT02418013
Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma
A Phase 1 study testing Fresh cord blood(experimental group A), Frozen cord blood(experimental group B) and Frozen plasma(experimental group C) in people with Aging, run by Bundang CHA Hospital at 1 site in South Korea.
Trial summary
This study aims to carry out a safety evaluation of human cord blood and frozen plasma as treatment for pre-frailty , to assess whether the treatment can prevent and improve the aging process, and to identify useful clinical markers of frailty. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Fresh cord blood(experimental group A), Frozen cord blood(experimental group B) and Frozen plasma(experimental group C)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pre-frailty
- One or two scores in Simple FRAIL questionnaire
- Aged 55 or over
- Willing and able to be hospitalized according to the research plan
- Able to participate in our research during 12 months
- For women, they must be diagnosed with menopause or infertility
Who cannot join
- Diagnosis of being irreversible disabled
- Dementia or cognitive impairment clinically relevant to it
- Unable to perform tasks required for analysis of primary end point
- Scheduled to receive organ transplantation
- Hemoglobin < 8 g/dl; white blood cells count <3000/mm3; absolute Neutrophil count < 500/dl; Thrombocyte count <80,000/mm3; , AST/ALT or ALP > 3 times the normal level
- Hemoglobin >17g/dl for male and >16 g/dl for female
Show all 19Show fewer
- Diagnosis of cancer within 5 years or having the possibility to contract cancer
- Anticancer chemotherapy and radiation therapy
- History (within 6 months) of acute diseases such as myocardial infarction, unstable angina, stroke, bone fracture
- Hormone therapy within 6 months
- Recent and current use of Immunosuppressive drug or HIV patients
- History of hospitalization due to infectious disease such as pneumonia within one year
- Previous (within one months) or current participants in other clinical trials
- Severe kidney (eGFR< 30) and heart failure (Class III/IV)
- Any participants who, in the opinion of the investigators, are considered to have safety problems and/or not to perform tasks successfully
- History of drug or alcohol abuse
- Chronic Hepatitis B or C: history taking
- Known or suspected pregnancy (Women must be subjected to pregnancy test)
- Hypersensitive to dimethyl sulfoxide(DMSO)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded and Placebo-controlled Pilot Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma by Clinical Markers of Frailty in Adult Who Defined Pre-Frailty
This study aims to carry out a safety evaluation of human cord blood and frozen plasma as treatment for pre-frailty , to assess whether the treatment can prevent and improve the aging process, and to identify useful clinical markers of frailty.
The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial conducted at CHA clinical trial institute.
Read the detailed description
Assessment criteria for the study include (1) clinical indicators-weight loss, a decrease in physical activity, weak grip strength, depression; (2) Short Physical Performance Battery(SPPB); (3) SF-36; (4)cardiac output; (4)biomarkers for oxidative stress, inflammation and immune response; (5) methylation; (6) mitochondria DNA copy number; (7) growth factors; (8) antioxidant capacity; (9) hormone assay; (10) genome assay; (11) metabolite; (12) safety of intravenous administration.
Participants will be randomly assigned to three experimental groups and one control group in a ratio of 1:1:1:1. At second visit, the participants will be administered with experimental and placebo agents. Follow-up visits are expected to be at 7 days, 1 and 6 months after the first treatment. Sixth visit is the completion of it.
Primary end points are defined as severe clinical abnormalities, which could be observed until 1 month after administration of blood-derived products, including death, pulmonary embolism, stroke, respiratory stress and hospitalization due to abnormal findings in laboratory tests.
- Conditions
- Aging
- Being tested
- Fresh cord blood(experimental group A), Frozen cord blood(experimental group B), Frozen plasma(experimental group C), Placebo group
- Keywords
- Frailty, Umbilical cord blood, Plasma, Randomized trial, Double-blinded trial, Placebo-controlled trial
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh cord blood(experimental group A)Other
- Cord blood is administered through intravenous at CHA clinical trail institute.
- Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered prior to the treatment.
Frozen cord blood(experimental group B)Other
- Cord blood is administered through intravenous at CHA clinical trail institute.
- Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered
Frozen plasma(experimental group C)Other
- Cord blood is administered through intravenous at CHA clinical trail institute.
- Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered
Placebo groupOther
A placebo agent is administered through intravenous at CHA clinical trail institute.
It should be certain that when administered, participants are not aware of which treatments are preformed.
| Study group | Role | What they receive |
|---|---|---|
| Fresh cord blood(experimental group A) | Experimental | 16 males and 16 females are assigned to the experimental group A. Dropout is 20 percent in each gender. Receives: Other: Fresh cord blood(experimental group A) |
| Frozen cord blood(experimental group B) | Experimental | 16 males and 16 females are assigned to the experimental group B. Dropout is 20 percent in each gender. Receives: Other: Frozen cord blood(experimental group B) |
| Frozen plasma(experimental group C) | Experimental | 16 males and 16 females are assigned to the experimental group C. Dropout is 20 percent in each gender. Receives: Other: Frozen plasma(experimental group C) |
| Placebo group | Placebo comparator | 16 males and 16 females are assigned to the Placebo group. Dropout is 20 percent in each gender. Total participants are 64 in males and 64 in females. Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
The investigators will assess changes in scores from baseline at 7 days after transplantation. After normality test, either unpaired t-test or wilcoxon rank sum test will be conducted.
Measured: 7 days after transplantation
Secondary outcomes (12)
Hand grip strength (in kg) as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation and at 1 week , 1 month, 6 months after the treatments. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
The followings are diagnosis criteria for frailty based on hand grip strength(in kg):
Male
- equal or less than 18 kg for the participants with BMI (body mass index)≤21.89
- equal or less than 23 kg for the participants with 22.02 <BMI≤23.63
- equal or less than 21.5 kg for the participants with 23.67<BMI≤24.63
- equal or less than 25 kg for the participants with BMI>24.88
Female
- equal or less than 12.2 kg for the participants with BMI (body mass index)≤22.52
- equal or less than 13 kg for the participants with 22.53<BMI ≤24.23
- equal or less than 14.5 kg for the participants with 24.24<BMI ≤26.44
- equal or less than 13 k
Measured: 6 months period after transplantation
SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. Changes in biomarkers such as CRP, IL-1,6, IL-10, LIF, D-dimer, fibrinogen, TNF-α, CBC with differential, malondialdehyde, 4-hydroxynonenal will be assessed. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
Biomarkers for immune response as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes of the immune-related biomarkers compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Followings are immune markers to be tested
-Eotaxin, FGF-2,Flt-3 Ligand ,Fractalkine,G-CSF, GM-CSF, GRO, IFNa2, IFNr, IL-1a, IL-1b, IL-1ra, IL-2, IL-3, IL-4 ,IL-5 ,IL-6 ,IL-7, IL-8, IL-9, IL-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IP-10, MCP-1, MCP-3, MDC, MIP-1a, MIP-1b, PDGF-AA, PDGF-AB/BB, RANTES, sCD40L, sIL-2Ra TGFa, TNFa,TNFb, VEGF
Measured: 6 months period after transplantation
Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes in hormone levels compared to baseline which will be measured at the day of transplantation.
After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: Up to 6 months after transplantation
Telomere length as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. Whether the treatments protect telomere from shortening will be investigated through the comparison analysis.
After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
Body composition as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes of body composition compared to baseline which will be measured at the day of transplantation.
After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
Aging-related genetic and epigenetic markers as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes of aging-related genetic markes (e.g ELOVL2. ) compared to baseline which will be measured at the day of transplantation.
After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
mitochondria DNA copy number as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. Mitochondria DNA copy number of participants will be compared among the treatment groups.
After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
Aging-related growth factors(GDF11, GDF15, Myostatin) as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes compared to baseline which will be measured at the day of transplantation. The factors will be compared among the treatment groups. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
DNA damage extent (8-hydroxyguanine level) as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes of 8-hydroxyguanine in white blood compared to baseline which will be measured at the day of transplantation.
After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments.
The investigators will assess changes in scores compared to baseline which will be measured at the day of transplantation.
After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Measured: 6 months period after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Ryool Park, Bundang CHA Hospital
- Investigators
- Myung Ryool Park, PhD, Principal investigator, orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418013
- Sponsor's protocol ID
- CHAIRB_BD_V.5.1_F011
- Status last verified
- Jan 2016
- First submitted
- 26 Mar 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded and Placebo-controlled Pilot Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma by Clinical Markers of Frailty in Adult Who Defined Pre-Frailty
- ClinicalTrials.gov ID
- NCT02418013
- Acronym / sponsor ID
- CHAIRB_BD_V.5.1_F011
- Conditions
- Aging
- Keywords
- Frailty, Umbilical cord blood, Plasma, Randomized trial, Double-blinded trial, Placebo-controlled trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to carry out a safety evaluation of human cord blood and frozen plasma as treatment for pre-frailty , to assess whether the treatment can prevent and improve the aging process, and to identify useful clinical markers of frailty.
The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial conducted at CHA clinical trial institute.
Detailed description
Assessment criteria for the study include (1) clinical indicators-weight loss, a decrease in physical activity, weak grip strength, depression; (2) Short Physical Performance Battery(SPPB); (3) SF-36; (4)cardiac output; (4)biomarkers for oxidative stress, inflammation and immune response; (5) methylation; (6) mitochondria DNA copy number; (7) growth factors; (8) antioxidant capacity; (9) hormone assay; (10) genome assay; (11) metabolite; (12) safety of intravenous administration.
Participants will be randomly assigned to three experimental groups and one control group in a ratio of 1:1:1:1. At second visit, the participants will be administered with experimental and placebo agents. Follow-up visits are expected to be at 7 days, 1 and 6 months after the first treatment. Sixth visit is the completion of it.
Primary end points are defined as severe clinical abnormalities, which could be observed until 1 month after administration of blood-derived products, including death, pulmonary embolism, stroke, respiratory stress and hospitalization due to abnormal findings in laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fresh cord blood(experimental group A) | Experimental | Other: Fresh cord blood(experimental group A)16 males and 16 females are assigned to the experimental group A. Dropout is 20 percent in each gender. |
| Frozen cord blood(experimental group B) | Experimental | Other: Frozen cord blood(experimental group B)16 males and 16 females are assigned to the experimental group B. Dropout is 20 percent in each gender. |
| Frozen plasma(experimental group C) | Experimental | Other: Frozen plasma(experimental group C)16 males and 16 females are assigned to the experimental group C. Dropout is 20 percent in each gender. |
| Placebo group | Placebo comparator | Other: Placebo group16 males and 16 females are assigned to the Placebo group. Dropout is 20 percent in each gender. Total participants are 64 in males and 64 in females. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of pre-frailty
- One or two scores in Simple FRAIL questionnaire
- Aged 55 or over
- Willing and able to be hospitalized according to the research plan
- Able to participate in our research during 12 months
Key exclusion criteria (19 listed)
- Diagnosis of being irreversible disabled
- Dementia or cognitive impairment clinically relevant to it
- Unable to perform tasks required for analysis of primary end point
- Scheduled to receive organ transplantation
- Hemoglobin < 8 g/dl; white blood cells count <3000/mm3; absolute Neutrophil count < 500/dl; Thrombocyte count <80,000/mm3; , AST/ALT or ALP > 3 times the normal level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh cord blood(experimental group A)1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered prior to the treatment. | Other | Fresh cord blood(experimental group A) |
| Frozen cord blood(experimental group B)1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered | Other | Frozen cord blood(experimental group B) |
| Frozen plasma(experimental group C)1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered | Other | Frozen plasma(experimental group C) |
| Placebo groupA placebo agent is administered through intravenous at CHA clinical trail institute. It should be certain that when administered, participants are not aware of which treatments are preformed. | Other | Placebo group |
Primary outcome
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
Time frame: 7 days after transplantation
The investigators will assess changes in scores from baseline at 7 days after transplantation. After normality test, either unpaired t-test or wilcoxon rank sum test will be conducted.
12 secondary outcomes
Hand grip strength (in kg) as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life
Time frame: 6 months period after transplantation
Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
Biomarkers for immune response as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects
Time frame: Up to 6 months after transplantation
Telomere length as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
Body composition as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
Aging-related genetic and epigenetic markers as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
mitochondria DNA copy number as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
Aging-related growth factors(GDF11, GDF15, Myostatin) as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
DNA damage extent (8-hydroxyguanine level) as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
Time frame: 6 months period after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung Ryool Park, PhD principal investigator
orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fresh cord blood(experimental group A), Frozen cord blood(experimental group B) and Frozen plasma(experimental group C) in people with Aging, run by Bundang CHA Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects (time frame: 7 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.