NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Humanitarian Use Device (HUD) Protocol for Use of Miltenyi CliniMACS (Registered Trademark) CD34 Reagent System in AML

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000867-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: N/A
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

AML;
Bone Marrow;
Reagent;
Cd34;
Non-Investigational

Recruitment Keyword(s)

None

Condition(s)

AML

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

Study Description:

This protocol enables use of a Humanitarian Use Device (HUD) indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission. HUDs are non-investigational devices approved for infrequent use based on evidence of safety and probably efficacy, in contrast to medical devices approved under Premarket Approval (PMA) based on evidence of safety and efficacy. IRB oversight is required for Humanitarian Device Exemption (HDE) from traditional marketing under 21 CFR 814.124.

Objectives:

There is no investigational objective. The objective is to provide independent ethics oversight of a lifesaving HUD approved on the basis of limited efficacy.

Endpoints:

There are no endpoints of this regulatory-compliance protocol.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must be a patient with AML in first morphologic complete remission (<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease).

EXCLUSION CRITERIA:

-Patients with known hypersensitivity to murine (mouse) proteins or iron dextran.

-Inability to meet the inclusion criteria.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kamille A. West-Mitchell, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C711
10 CENTER DR
BETHESDA MD 20814
(301) 594-5357
kamille.west@nih.gov

Kamille A. West-Mitchell, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C711
10 CENTER DR
BETHESDA MD 20814
(301) 594-5357
kamille.west@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Humanitarian Use Device (HUD) Protocol for Use of Miltenyi CliniMACS (Registered Trademark) CD34 Reagent System in AML

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000867-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: N/A
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

AML;
Bone Marrow;
Reagent;
Cd34;
Non-Investigational

Recruitment Keyword(s)

None

Condition(s)

AML

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

Study Description:

This protocol enables use of a Humanitarian Use Device (HUD) indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission. HUDs are non-investigational devices approved for infrequent use based on evidence of safety and probably efficacy, in contrast to medical devices approved under Premarket Approval (PMA) based on evidence of safety and efficacy. IRB oversight is required for Humanitarian Device Exemption (HDE) from traditional marketing under 21 CFR 814.124.

Objectives:

There is no investigational objective. The objective is to provide independent ethics oversight of a lifesaving HUD approved on the basis of limited efficacy.

Endpoints:

There are no endpoints of this regulatory-compliance protocol.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must be a patient with AML in first morphologic complete remission (<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease).

EXCLUSION CRITERIA:

-Patients with known hypersensitivity to murine (mouse) proteins or iron dextran.

-Inability to meet the inclusion criteria.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Kamille A. West-Mitchell, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C711
10 CENTER DR
BETHESDA MD 20814
(301) 594-5357
kamille.west@nih.gov

Kamille A. West-Mitchell, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C711
10 CENTER DR
BETHESDA MD 20814
(301) 594-5357
kamille.west@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

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