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

NCT01751282 | Terminated Phase 1 DMC

• 1 other identifier: RO1AR06034201A1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Healing Wounds

Keywords

Stem Cells; chronic wounds; fibrin; Bone marrow-derived mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• Wound closure

  24 weeks

Secondary Outcomes (1)

• Overall rate of wound healing reduction

  24 weeks

Study Arms (3)

Standard therapy and control saline spray

PLACEBO COMPARATOR

Conventional standard therapy and control saline spray

Genetic: Stem Cell

standard therapy and fibrin spray

SHAM COMPARATOR

Conventional standard therapy and fibrin spray

Genetic: Stem Cell

Conventional standard therapy and MSCs

EXPERIMENTAL

Conventional Standard Therapy and MSCs (autologous bone marrow-derived mesenchymal stem cells) in fibrin spray.

Genetic: Stem Cell

Interventions

Stem Cell GENETIC

Conventional standard therapy and MSCs; Standard therapy and control saline spray; standard therapy and fibrin spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roger Williams Medical Center: lead

Study Sites (1)

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

Study Officials

• Vincent Falanga, MD

  Roger Williams Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: June 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

US (1)