ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01751282
Recruitment Status : Terminated (Left Institution where study was approved)
First Posted : December 17, 2012
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Roger Williams Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Non Healing Wounds Genetic: Stem Cell Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Roger Williams Medical Center
ClinicalTrials.gov Identifier: NCT01751282     History of Changes
Other Study ID Numbers: RO1AR06034201A1
First Posted: December 17, 2012    Key Record Dates
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