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Study of the Effectiveness of Autologous Bone Marrow-Derived Mesenchymal Stem Cells in Fibrin to Treat Chronic Wounds

This study has been terminated.
(Left Institution where study was approved)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751282
First Posted: December 17, 2012
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roger Williams Medical Center
  Purpose
The purpose of this study is to determine the effectiveness of Autologous Bone Marrow-Derived Mesenchymal Stem Cells (MSCs) in the treatment of non-healing wounds.

Condition Intervention Phase
Non Healing Wounds Genetic: Stem Cell Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled Study to Evaluate the Effectiveness of the Use of Bone Marrow-Derived Mesenchymal Stem Cells (MSCs) in Fibrin in the Treatment of Chronic Wounds

Resource links provided by NLM:


Further study details as provided by Roger Williams Medical Center:

Primary Outcome Measures:
  • Wound closure [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Overall rate of wound healing reduction [ Time Frame: 24 weeks ]

Enrollment: 5
Study Start Date: June 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard therapy and control saline spray
Conventional standard therapy and control saline spray
Genetic: Stem Cell
Sham Comparator: standard therapy and fibrin spray
Conventional standard therapy and fibrin spray
Genetic: Stem Cell
Experimental: Conventional standard therapy and MSCs
Conventional Standard Therapy and MSCs (autologous bone marrow-derived mesenchymal stem cells) in fibrin spray.
Genetic: Stem Cell

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A subject must meet the following conditions in order to be included in this trial:

  • Male or female subjects 18 years of age or older with chronic wounds
  • Wound present for at least 3 months with no evidence of healing
  • Wound size must be less than or equal to 15 cm2 at randomization
  • Subjects must understand and give written informed consent
  • Subjects must agree to have biopsies performed as per protocol

Exclusion Criteria:

The presence of the following circumstances classifies a subject as unacceptable for inclusion in this trial:

  • Evidence of active infection at the wound site or around the ulcer
  • Requirement for the use of systemic corticosteroids or immuno- suppressive agents
  • The subject is pregnant or breast-feeding
  • The subject is known to be HIV positive
  • The subject is known to be Hepatitis B or C positive
  • Glycosylated hemoglobin A1C (HbA1C) is > 12%
  • Poor nutritional status (albumin < 2.0 g/dL)
  • The subject has a history of active, systemic malignancy
  • Clinical evidence of bone exposure within the wound bed
  • The subject has a history of noncompliance to medical regimens and is not considered reliable
  • The subject is unable to understand the study evaluations and provide a written informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751282


Locations
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Roger Williams Medical Center
Investigators
Principal Investigator: Vincent Falanga, MD Roger Williams Medical Center
  More Information

Responsible Party: Roger Williams Medical Center
ClinicalTrials.gov Identifier: NCT01751282     History of Changes
Other Study ID Numbers: RO1AR06034201A1
First Submitted: December 13, 2012
First Posted: December 17, 2012
Last Update Posted: October 4, 2016
Last Verified: October 2016

Keywords provided by Roger Williams Medical Center:
Stem Cells
chronic wounds
fibrin
Bone marrow-derived mesenchymal stem cells

Additional relevant MeSH terms:
Wounds and Injuries