Study to Evaluate Bone Marrow Cells in the Treatment of Chronic Wounds

NCT02319720 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: 200802995R01AG027874
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

Management of chronic wounds with:

1. 1.Bone Marrow Aspirate Plus Cultured Cells Group
2. 2.Cultured Cells Alone Group
3. 3.Bone Marrow Aspirate Alone Group
4. 4.Control Group

Conditions

Ulcer

Outcome Measures

Primary Outcomes (3)

• Safety Bone Marrow Fresh Cells directly to wounds (Number of adverse events)

  Number of adverse events reported

  12 months

• Safety Bone Marrow Cultured Cells directly to wounds (Number of adverse events)

  Number of adverse events reported

  12 months

• Safety Bone Marrow Cultured Cells and Bone Marrow fresh cells directly to wounds (Number of adverse events)

  Number of adverse events reported

  12 months

Secondary Outcomes (3)

• Efficacy Bone Marrow Fresh Cells in wounds (Healing rate)

  12 months

• Efficacy Bone Marrow Cultured Cells in wounds (Healing rate)

  12 months

• Efficacy Bone Marrow Cultured Cells and Bone Marrow Fresh Cells in wounds (Healing rate)

  12 months

Study Arms (4)

BMA/Cultured Bone Marrow Cells

EXPERIMENTAL

The subjects in this arm will have fresh bone marrow aspirate administered to the wound at the time the bone marrow is taken. Part of the aspirate will be cultured. Up to three applications of cultured cells will be applied to the wound following the bone marrow biopsy. A single treatment cycle will consist of one application of a freshly obtained bone marrow aspirate and up to three applications of cultured cells derived from that aspirate. If the wound has not healed, up to three additional treatment cycles may be performed. Each bone marrow biopsy will be followed by direct application of fresh bone marrow to the wound and up to three applications of cultured cells (prepared from the most recent bone marrow biopsy).

Biological: Bone Marrow Aspirate; Biological: Cultured Bone Marrow Cells; Procedure: Control

Cultured Bone Marrow Cells

EXPERIMENTAL

In this group, the bone marrow aspirate will be sent to the laboratory to be grown in tissue culture. Once the cell cultures have matured (within 8 weeks) they will be checked for sterility and frozen until applied to the subject's wound. Up to three applications of cultured cells will be applied to the wound following the bone marrow biopsy. A single treatment cycle will consist of up to three applications of cultured cells derived from a single bone marrow aspiration. If the wound has not healed, up to three additional treatment cycles may be performed. Each bone marrow biopsy will be followed by up to three applications of cultured cells (prepared from the most recent bone marrow biopsy).

Biological: Cultured Bone Marrow Cells; Procedure: Control

Bone Marrow Aspirate

EXPERIMENTAL

The subjects in this group will have fresh bone marrow aspirate administered to the wound at the time the bone marrow is taken. A single treatment cycle will consist of one application of a freshly obtained bone marrow aspirate. If the wound has not healed, up to three additional bone marrow biopsies may be performed. If the wound heals at any point during this protocol, no additional bone marrow biopsy procedures will be performed and no additional cells will be applied.

Biological: Bone Marrow Aspirate; Procedure: Control

Control

ACTIVE COMPARATOR

In this arm, subjects will receive currently approved treatments for their wound. These treatments will include debridement and dressing changes. Wound dressings allowed will include gauze, foam dressings, occlusive films, and non-stick pads. More advanced dressing materials such as Hydrocolloids, alginates, silver containing dressing and biomaterials can also be used. Compression will be utilized for lower extremity wounds.

Procedure: Control

Interventions

Bone Marrow Aspirate BIOLOGICAL

Fresh bone marrow aspirate administered to the wound at the time the bone marrow is taken.

BMA/Cultured Bone Marrow Cells; Bone Marrow Aspirate

Cultured Bone Marrow Cells BIOLOGICAL

The bone marrow aspirate will be sent to the laboratory to be grown in tissue culture. Once the cell cultures have matured (within 8 weeks) they will be checked for sterility and frozen until applied to the subject's wound.

BMA/Cultured Bone Marrow Cells; Cultured Bone Marrow Cells

Control PROCEDURE

The subjects in this group will receive currently approved treatments for their wound. These treatments will include debridement and dressing changes. Wound dressings allowed will include gauze, foam dressings, occlusive films, and non-stick pads. More advanced dressing materials such as Hydrocolloids, alginates, silver containing dressings, and biomaterials can also be used. Compression will be utilized for lower extremity wounds.

Also known as: Standard of Care

BMA/Cultured Bone Marrow Cells; Bone Marrow Aspirate; Control; Cultured Bone Marrow Cells

Eligibility Criteria

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

You may qualify if:

• Male or female subjects 18 years of age or older with chronic wounds
• Wound present for at least one year
• Subjects must understand and give written informed consent.
• Subjects must agree to have biopsies performed as per protocol
• Subjects must be accessible for weekly wound treatment and assessment visits
• Patients with chronic osteomyelitis will be eligible. They must however be afebrile, and have completed a 6-week course of intravenous and/or oral antibiotics. The use of chronic suppressive antibiotics will be allowed.

You may not qualify if:

• Have evidence of active infection at the wound site
• Evidence of active malignancy in ulcer
• Have any requirement for the use of systemic steroids or immunosuppressive agents
• Be a pregnant female or nursing mother
• Subjects who are known or found to be HIV positive
• Evidence of dry/wet gangrene
• History of alcohol or substance abuse within the past 18 months
• Patients with severe medical conditions
• Malignancy (other than non melanoma skin cancer) not in remission or in remission less than 5 years
• Life expectancy less than two years
• Severe cardiopulmonary disease restricting ambulation to the clinical facility
• Severe arterial or vascular disease requiring or best treated by amputation
• Untreated osteomyelitis affecting the ulcer area or osteomyelitis affecting the ulcer area not receiving aggressive treatment
• History of poor compliance, unreliability

Sponsors & Collaborators

• Dr. E.Badiavas: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Evangelos V Badiavas, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: July 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 30, 2018

Record last verified: 2018-04