Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma

Bundang CHA Hospital

Status and phase: Unknown; Phase 1

Conditions: Aging

Treatments: Other: Frozen plasma(experimental group C); Other: Frozen cord blood(experimental group B); Other: Placebo group; Other: Fresh cord blood(experimental group A)

Study type: Interventional

Funder types: Other

Identifiers

NCT02418013

CHAIRB_BD_V.5.1_F011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of pre-frailty
2. One or two scores in Simple FRAIL questionnaire
3. Aged 55 or over
4. Willing and able to be hospitalized according to the research plan
5. Able to participate in our research during 12 months
6. For women, they must be diagnosed with menopause or infertility

Exclusion criteria

1. Diagnosis of being irreversible disabled
2. Dementia or cognitive impairment clinically relevant to it
3. Unable to perform tasks required for analysis of primary end point
4. Scheduled to receive organ transplantation
5. 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
6. Hemoglobin >17g/dl for male and >16 g/dl for female
7. Diagnosis of cancer within 5 years or having the possibility to contract cancer
8. Anticancer chemotherapy and radiation therapy
9. History (within 6 months) of acute diseases such as myocardial infarction, unstable angina, stroke, bone fracture
10. Hormone therapy within 6 months
11. Recent and current use of Immunosuppressive drug or HIV patients
12. History of hospitalization due to infectious disease such as pneumonia within one year
13. Previous (within one months) or current participants in other clinical trials
14. Severe kidney (eGFR< 30) and heart failure (Class III/IV)
15. Any participants who, in the opinion of the investigators, are considered to have safety problems and/or not to perform tasks successfully
16. History of drug or alcohol abuse
17. Chronic Hepatitis B or C: history taking
18. Known or suspected pregnancy (Women must be subjected to pregnancy test)
19. Hypersensitive to dimethyl sulfoxide(DMSO)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 4 patient groups, including a placebo group

Fresh cord blood(experimental group A)

Experimental group

Description:

16 males and 16 females are assigned to the experimental group A. Dropout is 20 percent in each gender.

Treatment:

Other: Fresh cord blood(experimental group A)

Frozen cord blood(experimental group B)

Experimental group

Description:

16 males and 16 females are assigned to the experimental group B. Dropout is 20 percent in each gender.

Treatment:

Other: Frozen cord blood(experimental group B)

Frozen plasma(experimental group C)

Experimental group

Description:

16 males and 16 females are assigned to the experimental group C. Dropout is 20 percent in each gender.

Treatment:

Other: Frozen plasma(experimental group C)

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo group