The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds

Wounds Clinical Trial

Official title:

A Multi-Center Post- Marketing Study to Define Procedures for the Use of CureXcellTM in a Community Setting for the Treatment of Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113307
• Other study ID #: MC-103
• Status: Completed
• Phase: N/A
• First received: April 28, 2010
• Last updated: January 30, 2013
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: Macrocure Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services. Secondary objective is to evaluate the blinding method in a subgroup of patients, which will be used in a future study named: a multinational, multi-center, randomized, double blind, placebo controlled study for the evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer treatment, in diabetic patients with ulcers in the lower extremities.

Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcer will be recruited to the study. Patients that have been recruited for the study will be treated as required for their medical condition. As required, cultures will be taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will be referred to catheterization, revascularization, or amputation as required and the decision to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct treatment to good ulcer care (GUC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients between 18 and 90 years of age with one ulcer that has not shown signs of normal healing (according to physician experienced in wound therapy) for more than 3 weeks

2. The patient suffers from diabetic ulcer, decubitus ulcer, venous insufficiency ulcer and post operative wound.

3. In patients with suspected malnutrition albumin > 2.5 g/dL in blood tests performed within the last three weeks.

4. Patients with adequate blood perfusion: palpated distal pulses TP or DP or if not palpable, arterial pressures during rest ABI > 0.6.

5. Patients without edema over +2 (patient's edema must be controlled by medical and/or bandaging or lympha press).

6. Use of elastic bandaging in wounds due to venous insufficiency (when there is no involvement of an arterial problem).

7. Wound condition does not immediately jeopardize the extremity.

8. The patient's life is not at risk (for any reason).

9. The Patient has a life expectancy of at least one year.

10. Women of childbearing potential must be willing to use reliable methods of birth control.

11. Willing and able to sign an informed consent form and attend the follow up according to the treating staff instructions until complete wound closure.

Inclusion criteria in the 'treatment blinding guessing test':

1. A patient suffering from diabetes and a chronic ulcer in the lower extremity (ankle and below) and is CureXcell™ -naive.

2. Signing an appendix to the consent form for the 'treatment blinding guessing test'.

Exclusion Criteria:

1. More than one wound;

2. Inadequately treated recurrent pressure components in the wound. If required, ulcer will be treated with preliminary treatment for local pressure components (shoes and even cast or wheel chair for the treatment period)

3. Neoplastic ulcer

4. A patient with active malignant disease during the last five years, except for a patient suffering from adequately treated Basal Cell Carcinoma which does not present in the wound area.

5. Sepsis

6. Confirmed osteomyelitis

7. Patients suffering from significant immunosuppression.

8. INR > 3 in patients receiving anticoagulation drugs, in blood tests performed within two weeks prior to the first injection

9. A response to previous blood infusions (in case administered)

10. Patient receiving unique blood components (radiated, washed etc.)

11. Pregnant patient

12. Wounds for more than a year

13. A fistula/cavity which anatomical shape does not enable a direct injection into the wound

14. A patient participating in another clinical trial, or who participated in another clinical trial within the last 30 days.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wounds

Intervention

Biological:
• Activated allogeneic white blood cells
The CUREXCELL™ dosage form consists of an 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.The cell suspension is superficially injected throughout the wound bed ( 0.1ml per 1 cm2 of wound bed).

Locations

Country	Name	City	State
Israel	Omer Clalit Clinic	Afula
Israel	Sold Clalit Clinic	Be'er-Sheva
Israel	Hamoshava Diabetic Wound Clinic	Jerusalem
Israel	Ramat Eshcol Wound Clinic	Jerusalem
Israel	Zvulun Wound Clinic	Kiryat Bialik
Israel	Hasharon Medical Center	Petach Tikva
Israel	Zamenhoff Wound Clinic	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Macrocure Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with complete wound closure		Week 24	No
Secondary	Median time to complete wound closure		End of study	No
Secondary	Change in wound area between Baseline and Last Observation		End of study	No
Secondary	Rate of wound infections, cellulitis, and osteomyelitis		End of study	Yes