Safety Study of ECO Conversion System For Red Blood Cells. | NCT00261274

Studies
Safety Study of ECO Conversion System For Red Blood Cells.

NCT00261274

Sponsor

Velico Medical

Status

Completed

Last Update Posted

May 27, 2020Actual

Enrollment

Phase

Phase 1

Conditions

Anemia

Interventions

A-ECO
Saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Jan 2009Actual

Completion Date

Not provided

First Submitted Date

Nov 30, 2005

First Submission Date that Met QC Criteria

Nov 30, 2005

First Posted Date

Dec 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2020

Last Update Posted Date

May 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Label	Type	Description	Intervention Names
Test Group A-ECO	Experimental		Biological: A-ECO
Control Group	Placebo Comparator		Biological: Saline

Name	Type	Description	Arm Group Labels	Other Names
A-ECO	Biological		Test Group A-ECO
Saline

Measure	Description	Time Frame
Adverse events, clinically significant bruising over a period of 10 weeks.

Measure	Description	Time Frame
Unexpected lab test results over 10 weeks.

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kurt Gunter, MD	ZymeQuest, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Yale New Haven Hospital		New Haven	Connecticut	06510-3202	United States
University of Minnesota

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2562478	Background	Goldstein J. Conversion of ABO blood groups. Transfus Med Rev. 1989 Jul;3(3):206-12. doi: 10.1016/s0887-7963(89)70080-8.
6274021	Background	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.

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals