Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model

University Hospital Basel

Status and phase: Unknown; Phase 1

Conditions: Hematopoietic Stem Cells; Chronic Wounds; Wound Healing; Pressure Sores

Treatments: Biological: Stem cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00535548

552

Details and patient eligibility

About

Aim of the study:

Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using a pressure sore model.

Clinical relevance:

• Accelerated healing of uncomplicated wounds
• Enhanced healing of complicated (chronic, non-healing) wounds

Study design:

• Prospective controlled phase I/II study
• Cohort of 5 patients in pilot study, then reevaluation

Patients:

• Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the classification of Daniel and Seiler

Methods:

1. First surgical intervention:

• Radical debridement of pressure sore

• Bone marrow harvest from the iliac crest

• Isolation of hematopoietic stem cells, aiming to gain > 1 mio. CD 34+ cells per patient under GMP conditions

  3. Stem cell therapy (after 2 days)

• Injection of stem cells in suspension (50'000 CD 34+ cells in 100 microliter saline per cm2 of wound surface) on one half of the total wound surface and cell-free saline on the other half as a control

  4. Second surgical intervention (after 3-4 weeks):

• Complete excision of the wound

• Closure of the defect by fasciocutaneous flap

  5. Evaluation of wound healing:

• Clinical

• 3D laser imaging

• Histology

• Growth factor assay

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Para- or tetraplegic
• Sacral pressure sores
• Grade III-IV according to classification of Daniel and Seiler

Exclusion criteria

• Diabetes mellitus
• Peripheral vascular disease
• Coronary artery disease
• Smoking
• Steroids and other immunosuppressive drugs
• Systemic autoimmune or rheumatoid diseases
• HIV
• Hepatitis B/C

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind