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

Primary Purpose

Chronic Wounds, Pressure Sores, Hematopoietic Stem Cells

Status

Unknown status

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

Stem cell therapy

About this trial

This is an interventional basic science trial for Chronic Wounds focused on measuring Chronic wounds, Pressure sores, Hematopoietic stem cells, Wound healing

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Swiss Paraplegic CenterRecruiting

Outcomes

Primary Outcome Measures

feasibility, safety, efficacy

Secondary Outcome Measures

Full Information

NCT ID

NCT00535548

First Posted

September 24, 2007

Last Updated

September 24, 2007

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT00535548

Brief Title

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

Official Title

Effect of Hematopoietic Stem Cells in Chronic Wounds Using a Pressure Sore Model: A Pilot Study on Feasibility, Safety and Potential Effects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Wounds, Pressure Sores, Hematopoietic Stem Cells, Wound Healing

Keywords

Chronic wounds, Pressure sores, Hematopoietic stem cells, Wound healing

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Stem cell therapy

Intervention Description

Injection of a hematopoietic stem cell suspension (50'000 CD 34+ cells per microliter) into the wound (1 microliter per cm2 of wound surface)

Primary Outcome Measure Information:

Title

feasibility, safety, efficacy

Time Frame

1 yr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oliver Scheufler, MD, PhD

Phone

+41-61-265 2525

oscheufler@gmx.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Scheufler, MD, PhD

Organizational Affiliation

University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland

Official's Role

Study Director

Facility Information:

Facility Name

Swiss Paraplegic Center

City

Nottwil

ZIP/Postal Code

6207

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zweifel-Schlatter Mirjam, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

24476740

Citation

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.

Results Reference

derived

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

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