The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers

HemCon Medical Technologies

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Other: Fresh Frozen Plasma

Biological: Lyophilized Plasma

Study type

Interventional

Funder types

Industry

Identifiers

NCT00968487

2009-I-LyP-1

Details and patient eligibility

About

A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy volunteers.

Full description

This "first-in-human" Phase I, single-center, dose escalation study (using 3 dose levels) is proposed to assess the safety of infusing reconstituted lyophilized human plasma (LyP). The study design incorporates plasmapheresis-derived autologous plasma (FFP) for infusion(s) to eliminate variables and events known to be related to allogenic transfusion. Subjects will be enrolled at a blood center and provide autologous FFP that will be shipped to the sponsor site and used as the starting material to manufacture LyP. Once manufacturing is complete, the LyP (autologous) will be returned to the blood center for reconstitution and infusion into subjects. Maximum dosage within this study will approach "massive transfusion" (1 liter in Cohort 3) to obtain a preliminary assessment of safety. One half of the FFP obtained from subjects in Cohort 3 (only) will be shipped to the sponsor and returned to the site (but not manufactured into LyP) to serve as the control (autologous FFP).

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males and non-pregnant/ non-breast feeding females as they present interest
Minimum weight, 140 pounds (64 kg) or 175 pounds for Cohort 3 only
Ages 18-55 years
Subject self-reports that he/she feels well and healthy
Subject is able to donate one unit of whole blood based on the AABB donor history questionnaire with modifications indicated. Volunteers with history of travel which puts them at risk for vCJD will be eligible to participate.
Has read the educational materials on donating blood and has had his/her questions answered
Able and willing to provide informed consent
Available for the duration of the trial (approximately 8 weeks for Cohorts 1 and 2 and 12 weeks for Cohort 3) and able to come to the treatment clinic for scheduled study visits.
Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner.
Female subjects must have a negative serum pregnancy test prior to enrollment.
Understands the English language
Scored greater or equal to 35 on the Duke Activity Status Index (DSAI)

Exclusion criteria

Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/ metabolic, autoimmune or pulmonary disease; treated or untreated hypertension (see precise cut-off below)
Cancer of any kind, under treatment or resolved
Known or past coagulopathy conditions or blood disease
Currently using medications for anticoagulant therapy
Currently taking fish oil supplements
Any conditions, medications, etc. on the AABB medical deferral list
Previous use of clotting factor concentrate(s)
Past diagnosis of stroke or transient ischemic attack
Current or history of drug or alcohol abuse. Used needles to take drugs, steroids, or anything not prescribed by a doctor
Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness or received a positive test result for HIV infection.
Current or past infection with Hepatitis B or Hepatitis C virus
Has received positive test for Syphilis
Has received positive test for West Nile Virus
Female subject who is pregnant, lactating or with a positive pregnancy test
Currently taking an antibiotic or another medication for an infection.
Treatment or use of aspirin (or other platelet inhibiting agents) within 14 days of study donation and infusion visits
In the past week, has had a headache and fever at the same time.
Known intolerance to citric acid.
Receipt of blood or blood products within the past 12 months
Systolic blood pressure greater than 180 mmHg
Diastolic blood pressure greater than 90 mmHg
Temperature greater than 100° F
Hematocrit will not be less than 38% for both male and female donors
History of current mental or psychiatric condition
Treatment with any investigational agent within one month before treatment application for this trial
Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for follow-up visits on schedule
Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment
Subject is institutionalized because of legal or regulatory order
Other criteria based upon the AABB universal donor history questionnaire with the exception of travel to a vCJD area (i.e. travel to a vCJD area is not a study exclusion).
Has had any vaccinations or injections in the past 8 weeks.
Is a Medicare recipient
Is uninsured (does not have health care insurance)