- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261274
Safety Study of ECO Conversion System For Red Blood Cells.
May 22, 2020 updated by: Velico Medical
Evaluation of the Safety of Repeated Autologous Infusions of Enzyme-Converted A-to-O (A-ECO) Red Cells Into Group A Volunteers.
The purpose of this study is to demonstrate that small amounts of a person's own red cells, when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused, repeatedly.
Each participant will have some blood drawn, treated with an enzyme, washed and re-infused five times.
Additional samples of blood will be drawn for testing and evaluation.
Study Overview
Detailed Description
This study will involve a statistically valid number of subjects so that firm conclusions may be drawn about the safety of small volumes of A-ECO cells.
All participants will receive their own (autologous) red cells that have been either: 1) treated with an enzyme to create A-ECO cells (test group); or 2) washed with saline (control group).
The test and control groups will be compared for the rate and extent any adverse reactions or unexpected laboratory test results.
Study Type
Interventional
Enrollment
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510-3202
- Yale New Haven Hospital
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-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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-
New Mexico
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Albuquerque, New Mexico, United States, 87102
- TriCore Reference Laboratories
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Ohio
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Cincinnati, Ohio, United States, 45267-0055
- Hoxworth Blood Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19123
- American Red Cross Blood Services-Penn Jersey Region
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Virginia
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Norfolk, Virginia, United States, 23507
- American Red Cross
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteer subjects who have no clinically apparent cardiovascular, renal, pulmonary, endocrinological, autoimmune or neurological disorders
- Blood Group A
- Available for follow up periodically at varying intervals for twelve weeks
- Have a clinical presumption of a stable blood volume
- Between 18 and 65 years of age
- Able to provide informed consent
- Practicing contraception, other than oral or systemically delivered contraceptives, while participating in the study (subjects of potential reproductive age).
Exclusion Criteria:
- Women that are pregnant
- Persons with documented immune deficiencies
- Persons found to have abnormal platelet function or anti-platelet antibodies as determined by a pre-study screen
- Persons with a history of idiopathic thrombocytopenic purpura
- Persons who are bleeding or undergoing an active hemolytic process
- Persons who have any history of hemorrhagic tendency
- Persons who are taking any drug known to interfere with hemostasis, or who take combinations of drugs that have been reported to cause hemostatic problems or interfere with laboratory coagulation and platelet function testing
- Persons who test positive for von Willebrand's disease
- Persons taking investigational drugs or using an investigational device
- Persons with a family history of a bleeding disorder
- Persons with a history of vasculitis
- Persons with a history of a dermatological disorder that might be confused with bruising in the judgement of the investigator
- Persons with medical conditions which represent a contraindication to any study procedure, in the judgement of the investigator
- Persons with unexplained bruising
- Persons with abnormal laboratory screening tests
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control Group
|
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EXPERIMENTAL: Test Group A-ECO
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adverse events, clinically significant bruising over a period of 10 weeks.
|
Secondary Outcome Measures
Outcome Measure |
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Unexpected lab test results over 10 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kurt Gunter, MD, ZymeQuest, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Goldstein J. Conversion of ABO blood groups. Transfus Med Rev. 1989 Jul;3(3):206-12. doi: 10.1016/s0887-7963(89)70080-8.
- Goldstein J, Siviglia G, Hurst R, Lenny L, Reich L. Group B erythrocytes enzymatically converted to group O survive normally in A, B, and O individuals. Science. 1982 Jan 8;215(4529):168-70. doi: 10.1126/science.6274021.
- Goldstein J. Preparation of transfusable red cells by enzymatic conversion. Prog Clin Biol Res. 1984;165:139-57. No abstract available.
- Lenny LL, Hurst R, Zhu A, Goldstein J, Galbraith RA. Multiple-unit and second transfusions of red cells enzymatically converted from group B to group O: report on the end of phase 1 trials. Transfusion. 1995 Nov-Dec;35(11):899-902. doi: 10.1046/j.1537-2995.1995.351196110892.x.
- Lenny LL, Hurst R, Goldstein J, Benjamin LJ, Jones RL. Single-unit transfusions of RBC enzymatically converted from group B to group O to A and O normal volunteers. Blood. 1991 Mar 15;77(6):1383-8.
- Lenny LL, Goldstein J. The production of group O cells. Biotechnology. 1991;19:75-100. doi: 10.1016/b978-0-7506-9120-8.50009-3. No abstract available.
- Lenny LL, Hurst R, Goldstein J, Galbraith RA. Transfusions to group O subjects of 2 units of red cells enzymatically converted from group B to group O. Transfusion. 1994 Mar;34(3):209-14. doi: 10.1046/j.1537-2995.1994.34394196617.x.
- Kruskall MS, AuBuchon JP, Anthony KY, Herschel L, Pickard C, Biehl R, Horowitz M, Brambilla DJ, Popovsky MA. Transfusion to blood group A and O patients of group B RBCs that have been enzymatically converted to group O. Transfusion. 2000 Nov;40(11):1290-8. doi: 10.1046/j.1537-2995.2000.40111290.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (ACTUAL)
January 1, 2009
Study Registration Dates
First Submitted
November 30, 2005
First Submitted That Met QC Criteria
November 30, 2005
First Posted (ESTIMATE)
December 2, 2005
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 22, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 152-1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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