STEM CELL TRANSPLANTATION FOR THE TREATMENT OF AUTOIMMUNE DISEASES

Release Date:  February 26, 1999

RFP AVAILABLE:  NIH-NIAID-DAIT-BAA-99-31

P.T.

National Institute of Allergy and Infectious Diseases

The Division of Allergy, Immunology and Transplantation (DAIT) of the National
Institute of Allergy and Infectious Diseases (NIAID), in collaboration with the
National Heart, Lung and Blood Institute (NHLBI), the National Institute of Child
Health and Human Development (NICHD), the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), the National Institute of Dental and
Craniofacial Research (NIDCR), and the Office of Research on Women's Health,
(ORWH) has a requirement for Contractors to conduct clinical research on stem
cell transplantation for the treatment of multiple autoimmune diseases.  This
solicitation requests proposals for development and implementation of clinical
trials utilizing hematopoietic stem cells for the treatment of autoimmune
disease.  Hematopoietic stem cell transplantation is routinely performed for
treatment of leukemia and other cancers.  The hematopoetic stem cells utilized
in these procedures are distinct from human pluripotent stem cells derived from
human fetuses or human embryos.  At this time NIH funds should not be used to
support or conduct research using human pluripotent stem cells.

The overall purposes of this Broad Agency Announcement (BAA) are to solicit
proposals to:  (1) support clinical trials, including randomized controlled
trials, of the safety, toxicity and efficacy of stem cell transplantation as a
treatment for autoimmune diseases; (2) develop and perform integrated research
studies to examine underlying mechanisms, including the identification and
assessment of immunologic and other relevant parameters responsible for and/or
associated with response to therapy, short- and long-term clinical outcome, and
recurrence/remission of the underlying autoimmune disease; and, (3) an optional
component focused on the establishment of core resources/repositories useful for
further basic and clinical research on stem cell transplantation.  Each
contractor shall be required to design and conduct clinical trials in more than
one autoimmune disease.  Clinical trials shall be proposed for any autoimmune
diseases, including but not limited to: multiple sclerosis, systemic lupus
erythematosus, type 1 diabetes, scleroderma, inflammatory bowel disease,
idiopathic thrombocytopenia, autoimmune hemolytic anemia, and rheumatoid
arthritis.  It is expected that these clinical trials will allow determination
of the safety, efficacy, and patients most likely to benefit from this new
therapeutic approach to autoimmune diseases.

Request for Proposals (RFP) NIH-NIAID-DAIT-BAA-99-31 is available at the
following URL:  http://www.niaid.nih.gov/contract and select the "RFPs" link.

Please note that the RFP for this acquisition has been revised to include only
the Research and Technical Objectives, deliverable and reporting requirements,
special requirements, and mandatory qualifications, if any, the Technical
Evaluation Criteria, and the proposal preparation instructions.  All information
required for the submission of an offer will be contained in the electronic RFP
package.  Following proposal submission and review, offerors may be requested to
provide additional documentation to the Contracting Officer.

Proposals in response to this RFP will be due on or about March 31, 1999.  Any
responsible offeror may submit a proposal, which will be considered by the
Government.  This advertisement does not commit the Government to award a
contract.

It is anticipated that two cost-reimbursement contracts will be awarded for a
maximum period of five years.

INQUIRIES

Inquiries concerning this RFP may be directed to:

Cyndie Cotter, Contracting Officer
Telephone:  (301) 402-0641
FAX:  (301) 402-0972
Email:  cc41w@nih.gov

No collect calls will be accepted.

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