WoundsNCT01038986
A Post-marketing Observational Study of Cell Therapy for Chronic Wounds
An observational study of Wounds, run by Macrocure Ltd. at 3 sites in Israel.
Trial summary
A post-marketing multi-center observational study to provide data describing the safety and effectiveness of CUREXCELL™ as it is applied in a real-life setting for treatment in patients with chronic and/or refractory wounds. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds
- What is being tested?
- CureXcell
- How many people
- 70 participants
- Where
- 3 sitesIsrael
- Study dates
- Dec 2009to Oct 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic and/or refractory wounds that have been referred by their physician for CureXcell treatment
Who may be able to join
- Patients with chronic and/or refractory wounds that have been referred by their physician for CUREXCELLTM treatment
- Signed consent form
- Patients with chronic lower extremity ulcers (on malleoli and below) and diabetes mellitus
- Signed the blinding guessing test section of the consent form
- Were not treated in the past by CureXcell
Who cannot join
- Patients with known or suspected present malignancy (except for successfully treated basal cell carcinoma) within the past 3 years.
- Patients with gangrene
- Patients for whom amputation or a complete resection of the infection site is planned component of treatment
- Patients simultaneously participating in any interventional clinical trial
- Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Rambam Health Care Campus
Haifa, 9602
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Tel HaShomer
About this study
Official title: A Post-marketing Multi-center Observational Study to Provide Data Describing the Safety and Effectiveness of CUREXCELL™ as it is Applied in a Real-life Setting for Treatment in Patients With Chronic and/or Refractory Wounds
A post-marketing multi-center observational study to provide data describing the safety and effectiveness of CUREXCELL™ as it is applied in a real-life setting for treatment in patients with chronic and/or refractory wounds.
Read the detailed description
Chronic wounds can be categorized into two main groups: (a) chronic ulcers, such as diabetic foot ulcers, venous leg ulcers and pressure (decubitus) ulcers (b) post-operative or traumatic, difficult-to-heal wounds, some of which may be infected such as sternal wound infections following cardiac surgery or wounds following abdominal or orthopedic surgery. Age, peripheral vascular disease, infection, diabetes mellitus, auto-immune dis., obesity, cardiac disease, cardiac failure, malnutrition, immunological deficiencies, steroid treatment, bed confinement and prolonged operation time are among the causes of wound repair delay or failure and often results in considerable morbidity and mortality. In addition, these wounds lengthen hospital stays, significantly increase the cost of care, and negatively impact the quality of life of both the patients and care giversCurrently available wound care products include various dressings, ointments, gels, antiseptic agents and devices. These products are intended to supply a suitable environment for wound healing (e.g. moist environment, particular factors required for the healing process), but they do not provide an adequate solution for this growing problem of chronic wounds.
Macrocure has developed an advanced cellular therapy for wound healing named Curexcell™. Curexcell™ not only provides the natural environment for wound healing, but also ensures that the appropriate cell activities and factor secretions are maintained as required during each of the stages of wound healing. The product contains primed/activated Monocytes, Neutrophils and Lymphocytes derived from whole blood unit, which are key role players in the normal natural wound healing process. The cells are injected locally into the wound bed.
The proposed study is a post-marketing observational study (PMOS) in which the decision to use Curexcell™ for treatment of patients with chronic and/or refractory wounds are made by local physicians. Curexcell™ will be administered to the patient in accordance with the Instructions for Use.
In this PMOS, there is no control by the investigator with respect to patients, duration and frequency of follow-up and the method by which patients are managed in general. This design truly reflects real-life circumstances.
- Conditions
- Wounds
- Being tested
- CureXcell
- Keywords
- chronic wound, refractory wound, CureXcell, activated cell suspension
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CureXcellBiological
The CureXcell™ dosage form consists of an aseptically-processed activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.
| Study group | Role | What they receive |
|---|---|---|
| CureXcell treated | Patients with chronic and/or refractory wounds for at least 4 weeks with no improvement that have been referred by their physician for CureXcell treatment Receives: Biological: CureXcell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and frequency of adverse experiences
Measured: 3 years
Secondary outcomes (1)
Percent of complete healing following CureXcell™ treatments
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macrocure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Itzchak Zivner, MD, Principal investigator, Sheba Medical CenterEli Peled, M.D., Principal investigator, Rambam Health Care Campus, IsraelDean David Ad-El, M.D., Principal investigator, Rabin-Schnider Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038986
- Sponsor's protocol ID
- MC101-IL-01
- Status last verified
- Jan 2013
- First submitted
- 23 Dec 2009
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Leor J, Rozen L, Zuloff-Shani A, Feinberg MS, Amsalem Y, Barbash IM, Kachel E, Holbova R, Mardor Y, Daniels D, Ocherashvilli A, Orenstein A, Danon D. Ex vivo activated human macrophages improve healing, remodeling, and function of the infarcted heart. Circulation. 2006 Jul 4;114(1 Suppl):I94-100. doi: 10.1161/CIRCULATIONAHA.105.000331.
PubMed 16820652Orenstein A, Kachel E, Zuloff-Shani A, Paz Y, Sarig O, Haik J, Smolinsky AK, Mohr R, Shinar E, Danon D. Treatment of deep sternal wound infections post-open heart surgery by application of activated macrophage suspension. Wound Repair Regen. 2005 May-Jun;13(3):237-42. doi: 10.1111/j.1067-1927.2005.130304.x.
PubMed 15953041Zuloff-Shani A, Kachel E, Frenkel O, Orenstein A, Shinar E, Danon D. Macrophage suspensions prepared from a blood unit for treatment of refractory human ulcers. Transfus Apher Sci. 2004 Apr;30(2):163-7. doi: 10.1016/j.transci.2003.11.007.
PubMed 15062757Frenkel O, Shani E, Ben-Bassat I, Brok-Simoni F, Rozenfeld-Granot G, Kajakaro G, Rechavi G, Amariglio N, Shinar E, Danon D. Activated macrophages for treating skin ulceration: gene expression in human monocytes after hypo-osmotic shock. Clin Exp Immunol. 2002 Apr;128(1):59-66. doi: 10.1046/j.1365-2249.2002.01630.x.
PubMed 11982591Danon D, Kowatch MA, Roth GS. Promotion of wound repair in old mice by local injection of macrophages. Proc Natl Acad Sci U S A. 1989 Mar;86(6):2018-20. doi: 10.1073/pnas.86.6.2018.
PubMed 2928316
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Multi-center Observational Study to Provide Data Describing the Safety and Effectiveness of CUREXCELL™ as it is Applied in a Real-life Setting for Treatment in Patients With Chronic and/or Refractory Wounds
- ClinicalTrials.gov ID
- NCT01038986
- Acronym / sponsor ID
- MC101-IL-01
- Conditions
- Wounds
- Keywords
- chronic wound, refractory wound, CureXcell, activated cell suspension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Macrocure Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Dec 2009 (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.
A post-marketing multi-center observational study to provide data describing the safety and effectiveness of CUREXCELL™ as it is applied in a real-life setting for treatment in patients with chronic and/or refractory wounds.
Detailed description
Chronic wounds can be categorized into two main groups: (a) chronic ulcers, such as diabetic foot ulcers, venous leg ulcers and pressure (decubitus) ulcers (b) post-operative or traumatic, difficult-to-heal wounds, some of which may be infected such as sternal wound infections following cardiac surgery or wounds following abdominal or orthopedic surgery. Age, peripheral vascular disease, infection, diabetes mellitus, auto-immune dis., obesity, cardiac disease, cardiac failure, malnutrition, immunological deficiencies, steroid treatment, bed confinement and prolonged operation time are among the causes of wound repair delay or failure and often results in considerable morbidity and mortality. In addition, these wounds lengthen hospital stays, significantly increase the cost of care, and negatively impact the quality of life of both the patients and care giversCurrently available wound care products include various dressings, ointments, gels, antiseptic agents and devices. These products are intended to supply a suitable environment for wound healing (e.g. moist environment, particular factors required for the healing process), but they do not provide an adequate solution for this growing problem of chronic wounds.
Macrocure has developed an advanced cellular therapy for wound healing named Curexcell™. Curexcell™ not only provides the natural environment for wound healing, but also ensures that the appropriate cell activities and factor secretions are maintained as required during each of the stages of wound healing. The product contains primed/activated Monocytes, Neutrophils and Lymphocytes derived from whole blood unit, which are key role players in the normal natural wound healing process. The cells are injected locally into the wound bed.
The proposed study is a post-marketing observational study (PMOS) in which the decision to use Curexcell™ for treatment of patients with chronic and/or refractory wounds are made by local physicians. Curexcell™ will be administered to the patient in accordance with the Instructions for Use.
In this PMOS, there is no control by the investigator with respect to patients, duration and frequency of follow-up and the method by which patients are managed in general. This design truly reflects real-life circumstances.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CureXcell treated | – | Biological: CureXcellPatients with chronic and/or refractory wounds for at least 4 weeks with no improvement that have been referred by their physician for CureXcell treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic and/or refractory wounds that have been referred by their physician for CureXcell treatment
Key inclusion criteria (5 listed)
- Patients with chronic and/or refractory wounds that have been referred by their physician for CUREXCELLTM treatment
- Signed consent form
- Patients with chronic lower extremity ulcers (on malleoli and below) and diabetes mellitus
- Signed the blinding guessing test section of the consent form
- Were not treated in the past by CureXcell
Key exclusion criteria (5 listed)
- Patients with known or suspected present malignancy (except for successfully treated basal cell carcinoma) within the past 3 years.
- Patients with gangrene
- Patients for whom amputation or a complete resection of the infection site is planned component of treatment
- Patients simultaneously participating in any interventional clinical trial
- Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements
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 |
|---|---|---|
| CureXcellThe CureXcell™ dosage form consists of an aseptically-processed activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system. | Biological | CureXcell treated |
Primary outcome
Incidence and frequency of adverse experiences
Time frame: 3 years
1 secondary outcome
Percent of complete healing following CureXcell™ treatments
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Background: PubMed 16820652Leor J, Rozen L, Zuloff-Shani A, Feinberg MS, Amsalem Y, Barbash IM, Kachel E, Holbova R, Mardor Y, Daniels D, Ocherashvilli A, Orenstein A, Danon D. Ex vivo activated human macrophages improve healing, remodeling, and function of the infarcted heart. Circulation. 2006 Jul 4;114(1 Suppl):I94-100. doi: 10.1161/CIRCULATIONAHA.105.000331.
- Background: PubMed 15953041Orenstein A, Kachel E, Zuloff-Shani A, Paz Y, Sarig O, Haik J, Smolinsky AK, Mohr R, Shinar E, Danon D. Treatment of deep sternal wound infections post-open heart surgery by application of activated macrophage suspension. Wound Repair Regen. 2005 May-Jun;13(3):237-42. doi: 10.1111/j.1067-1927.2005.130304.x.
- Background: PubMed 15062757Zuloff-Shani A, Kachel E, Frenkel O, Orenstein A, Shinar E, Danon D. Macrophage suspensions prepared from a blood unit for treatment of refractory human ulcers. Transfus Apher Sci. 2004 Apr;30(2):163-7. doi: 10.1016/j.transci.2003.11.007.
- Background: PubMed 11982591Frenkel O, Shani E, Ben-Bassat I, Brok-Simoni F, Rozenfeld-Granot G, Kajakaro G, Rechavi G, Amariglio N, Shinar E, Danon D. Activated macrophages for treating skin ulceration: gene expression in human monocytes after hypo-osmotic shock. Clin Exp Immunol. 2002 Apr;128(1):59-66. doi: 10.1046/j.1365-2249.2002.01630.x.
- Background: PubMed 2928316Danon D, Kowatch MA, Roth GS. Promotion of wound repair in old mice by local injection of macrophages. Proc Natl Acad Sci U S A. 1989 Mar;86(6):2018-20. doi: 10.1073/pnas.86.6.2018.
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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.
Itzchak Zivner, MD principal investigator
Sheba Medical Center
Eli Peled, M.D. principal investigator
Rambam Health Care Campus, Israel
Dean David Ad-El, M.D. principal investigator
Rabin-Schnider Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by Macrocure Ltd. at 3 sites in Israel.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and frequency of adverse experiences (time frame: 3 years). 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 NCT01038986, which also lists 5 linked publications.
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 31 Jan 2013.