Clinical Trial: Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants


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Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

This study is currently recruiting patients.

Sponsored by:	FDA Office of Orphan Products Development University of Michigan
Information provided by:	FDA Office of Orphan Products Development

Purpose

This is a single arm dose escalation study of recombinant human keratinocyte growth factor given to patients undergoing allogeneic bone marrow transplantation who are at high risk for graft versus host disease (GVHD).

Condition	Treatment or Intervention	Phase
Graft Versus Host Disease	Drug: recombinant human keratinocyte growth factor	Phase I Phase II

MedlinePlus related topics: Immune System and Disorders

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Historical Control, Safety/Efficacy Study

Official Title: Safety and Efficacy of Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

Further Study Details:

Expected Total Enrollment: 50

Study start: September 2002; Study completion: September 2005

Eligibility

Ages Eligible for Study: 3 Years - 65 Years, Genders Eligible for Study: Both

Criteria

Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor

Location and Contact Information

Christopher Reynolds, MD 734-936-8785 chreynol@med.umich.edu

Michigan
University of Michigan Cancer Center, Ann Arbor, Michigan, 48109, United States; Recruiting

Christopher Reynolds, MD 734-936-8785 chreynol@med.umich.edu
James Ferrara, MD 734-615-1340 Ferrara@umich.edu
James Ferrara, MD, Sub-Investigator
Christopher Reynolds, MD, Principal Investigator

More Information

Study ID Numbers: 2146
Record last reviewed: June 2001
Record first received: March 25, 2003
ClinicalTrials.gov Identifier: NCT00056875
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09

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