AnemiaPhase 1NCT00261274
Safety Study of ECO Conversion System For Red Blood Cells.
A Phase 1 study testing A-ECO and Saline in people with Anemia, run by Velico Medical at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- A-ECO and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2005to Jan 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
TriCore Reference Laboratories
Albuquerque, New Mexico, 87102
Hoxworth Blood Center
Cincinnati, Ohio, 45267-0055
University of Minnesota
Minneapolis, Minnesota, 55455
Yale New Haven Hospital
New Haven, Connecticut, 06510-3202
American Red Cross
Norfolk, Virginia, 23507
American Red Cross Blood Services-Penn Jersey Region
Philadelphia, Pennsylvania, 19123
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia
- Being tested
- A-ECO, Saline
- Keywords
- transfusion; red blood cells
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-ECOBiological
SalineBiological
| Study group | Role | What they receive |
|---|---|---|
| Test Group A-ECO | Experimental | Not described Receives: Biological: A-ECO |
| Control Group | Placebo comparator | Not described Receives: Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, clinically significant bruising over a period of 10 weeks.
Secondary outcomes (1)
Unexpected lab test results over 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Velico Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Gunter, MD, Study director, ZymeQuest, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261274
- Sponsor's protocol ID
- 152-1001
- Status last verified
- May 2020
- First submitted
- 30 Nov 2005
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 2562478Goldstein 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.
PubMed 6274021Goldstein J. Preparation of transfusable red cells by enzymatic conversion. Prog Clin Biol Res. 1984;165:139-57. No abstract available.
PubMed 6095313Lenny 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.
PubMed 8604485Lenny 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.
PubMed 1848117Lenny 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.
PubMed 1664756Lenny 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.
PubMed 8146892Kruskall 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.
PubMed 11099655
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of Repeated Autologous Infusions of Enzyme-Converted A-to-O (A-ECO) Red Cells Into Group A Volunteers.
- ClinicalTrials.gov ID
- NCT00261274
- Acronym / sponsor ID
- 152-1001
- Conditions
- Anemia
- Keywords
- transfusion; red blood cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Velico MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jan 2009 (actual)
- First posted
- 2 Dec 2005 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group A-ECO | Experimental | Biological: A-ECO |
| Control Group | Placebo comparator | Biological: Saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| A-ECO | Biological | Test Group A-ECO |
| Saline | Biological | Control Group |
Primary outcome
Adverse events, clinically significant bruising over a period of 10 weeks.
1 secondary outcome
Unexpected lab test results over 10 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 2562478Goldstein J. Conversion of ABO blood groups. Transfus Med Rev. 1989 Jul;3(3):206-12. doi: 10.1016/s0887-7963(89)70080-8.
- Background: PubMed 6274021Goldstein 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.
- Background: PubMed 6095313Goldstein J. Preparation of transfusable red cells by enzymatic conversion. Prog Clin Biol Res. 1984;165:139-57. No abstract available.
- Background: PubMed 8604485Lenny 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.
- Background: PubMed 1848117Lenny 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.
- Background: PubMed 1664756Lenny 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.
- Background: PubMed 8146892Lenny 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.
- Background: PubMed 11099655Kruskall 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.
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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.
Kurt Gunter, MD study director
ZymeQuest, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A-ECO and Saline in people with Anemia, run by Velico Medical at 6 sites in United States.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events, clinically significant bruising over a period of 10 weeks.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00261274, which also lists 8 linked publications.
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 27 May 2020.