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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roger Williams Medical Center
ClinicalTrials.gov Identifier:
NCT01751282
First received: December 13, 2012
Last updated: August 1, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Roger Williams Medical Center:

Primary Outcome Measures:
  • Wound closure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall rate of wound healing reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Roger Williams Medical Center
ClinicalTrials.gov Identifier: NCT01751282     History of Changes
Other Study ID Numbers: RO1AR06034201A1
Study First Received: December 13, 2012
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014