NCT02418013

Brief 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. The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial conducted at CHA clinical trial institute.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

March 26, 2015

Last Update Submit

January 11, 2016

Conditions

Aging

Keywords

FrailtyUmbilical cord bloodPlasmaRandomized trialDouble-blinded trialPlacebo-controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days after transplantation

Secondary Outcomes (12)

  • Hand grip strength (in kg) as a measure of efficacy for anti-aging effects

    6 months period after transplantation

  • SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life

    6 months period after transplantation

  • Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects

    6 months period after transplantation

  • Biomarkers for immune response as a measure of efficacy for anti-aging effects

    6 months period after transplantation

  • Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects

    Up to 6 months after transplantation

  • +7 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Other: Placebo group

Interventions

Fresh cord blood(experimental group A)OTHER

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.

Fresh cord blood(experimental group A)
Frozen cord blood(experimental group B)OTHER

1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered

Frozen cord blood(experimental group B)
Frozen plasma(experimental group C)OTHER

1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered

Frozen plasma(experimental group C)
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.

Placebo group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundang CHA hospital

Seongnam, Bundanggu, 463, South Korea

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Myung Ryool Park, PhD

    orthopedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2015

First Posted

April 16, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

KR(1)