Chronic WoundsPhase 1NCT00535548
Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model
A Phase 1 study testing Stem cell therapy in people with Chronic Wounds and Pressure Sores, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Wounds, Pressure Sores, Hematopoietic Stem Cells
- What is being tested?
- Stem cell therapy
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2007to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Para- or tetraplegic
- Sacral pressure sores
- Grade III-IV according to classification of Daniel and Seiler
Who cannot join
- Diabetes mellitus
- Peripheral vascular disease
- Coronary artery disease
- Smoking
- Steroids and other immunosuppressive drugs
- Systemic autoimmune or rheumatoid diseases
- HIV
- Hepatitis B/C
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Center
Nottwil, 6207
Zweifel-Schlatter Mirjam, MD
About this study
Official title: Effect of Hematopoietic Stem Cells in Chronic Wounds Using a Pressure Sore Model: A Pilot Study on Feasibility, Safety and Potential Effects
Aim of the study:
Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using a pressure sore model.
Read more
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:
- 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
- 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
- Second surgical intervention (after 3-4 weeks):
- Complete excision of the wound
- Closure of the defect by fasciocutaneous flap
- Evaluation of wound healing:
- Clinical
- 3D laser imaging
- Histology
- Growth factor assay
- Being tested
- Stem cell therapy
- Keywords
- Chronic wounds, Pressure sores, Hematopoietic stem cells, Wound healing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell therapyBiological
Injection of a hematopoietic stem cell suspension (50'000 CD 34+ cells per microliter) into the wound (1 microliter per cm2 of wound surface)
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility, safety, efficacy
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJan 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Oliver Scheufler, MD, PhD, Study director, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535548
- Sponsor's protocol ID
- 552
- Status last verified
- Sep 2007
- First submitted
- 24 Sep 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24476740
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hematopoietic Stem Cells in Chronic Wounds Using a Pressure Sore Model: A Pilot Study on Feasibility, Safety and Potential Effects
- ClinicalTrials.gov ID
- NCT00535548
- Acronym / sponsor ID
- 552
- Keywords
- Chronic wounds, Pressure sores, Hematopoietic stem cells, Wound healing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- Second surgical intervention (after 3-4 weeks):
- Complete excision of the wound
- Closure of the defect by fasciocutaneous flap
- Evaluation of wound healing:
- Clinical
- 3D laser imaging
- Histology
- Growth factor assay
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Para- or tetraplegic
- Sacral pressure sores
- Grade III-IV according to classification of Daniel and Seiler
Key exclusion criteria (8 listed)
- Diabetes mellitus
- Peripheral vascular disease
- Coronary artery disease
- Smoking
- Steroids and other immunosuppressive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cell therapyInjection of a hematopoietic stem cell suspension (50'000 CD 34+ cells per microliter) into the wound (1 microliter per cm2 of wound surface) | Biological | – |
Primary outcome
feasibility, safety, efficacy
Time frame: 1 yr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2007.
- Derived from this study: PubMed 24476740Wettstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Scheufler, MD, PhD study director
University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stem cell therapy in people with Chronic Wounds and Pressure Sores, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Scheufler, MD, PhD (+41-61-265 2525, oscheufler@gmx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility, safety, efficacy (time frame: 1 yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2007.