Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model
NCT ID: NCT00535548
Last Updated: 2007-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
INTERVENTIONAL
2007-01-31
2007-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Interventions
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Stem cell therapy
Injection of a hematopoietic stem cell suspension (50'000 CD 34+ cells per microliter) into the wound (1 microliter per cm2 of wound surface)
Eligibility Criteria
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Inclusion Criteria
* Sacral pressure sores
* Grade III-IV according to classification of Daniel and Seiler
Exclusion Criteria
* Peripheral vascular disease
* Coronary artery disease
* Smoking
* Steroids and other immunosuppressive drugs
* Systemic autoimmune or rheumatoid diseases
* HIV
* Hepatitis B/C
18 Years
50 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Principal Investigators
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Oliver Scheufler, MD, PhD
Role: STUDY_DIRECTOR
University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland
Locations
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Swiss Paraplegic Center
Nottwil, , Switzerland
Countries
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Central Contacts
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References
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Wettstein R, Savic M, Pierer G, Scheufler O, Haug M, Halter J, Gratwohl A, Baumberger M, Schaefer DJ, Kalbermatten DF. Progenitor cell therapy for sacral pressure sore: a pilot study with a novel human chronic wound model. Stem Cell Res Ther. 2014 Jan 29;5(1):18. doi: 10.1186/scrt407.
Other Identifiers
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552
Identifier Type: -
Identifier Source: org_study_id