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Treatment of Chronic Wounds in Diabetic Foot Syndrome With Autologous Adipose Derived Mesenchymal Stem Cells (1ABC)

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ClinicalTrials.gov Identifier: NCT03865394
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Laboratory for Cell Research and Application, Medical University of Warsaw
Gen. Surgery, Vascular and Transplantation Dept., Medical University of Warsaw
Polish Stem Cells Bank S.A.
Information provided by (Responsible Party):
Medical University of Warsaw

Brief Summary:
The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Biological: Application of autologous ADSC stem cells in fibrin gel Procedure: Standard care in diabetic foot ulcer Phase 1 Phase 2

Detailed Description:
The product will contain an active ingredient- human autologous adipose-derived mesenchymal stem cells (ADSC) cells suspended in the fibrin solution applied directly onto prepared wound bed, to form thin gel layer on the wound surface.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of the Treatment of Chronic Wounds in Diabetic Foot Syndrome With the Use of Autologous Stem Cells Isolated From Adipose Tissue
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : May 23, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous ADSC cells in fibrin solution

Application of autologous ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer.

Therapy is based on standard procedure of diabetic foot ulcer treatment combined with application onto the wound surface autologous ADSC stem cell in fibrin solution.

Biological: Application of autologous ADSC stem cells in fibrin gel
Chronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - three doses will be administered at two weeks intervals.

Active Comparator: Standard care in diabetic foot ulcer
Retrospective analysis of treatment outome in patients who underwent standard care procedure in diabetic foot ulcer treatment
Procedure: Standard care in diabetic foot ulcer
Chronic wounds in diabetic foot ulcer will be treated with standard procedure.




Primary Outcome Measures :
  1. Changes in wound size [ Time Frame: 6 weeks ]

    Evaluation of wound size changes using digital 3D wound imaging medical device and image processing.

    The wound changes will be assessed according to the following rules:

    • for wound deeper than 0,5 cm - measurement of changes in wound volume, or
    • for shallow wound (less than 0,5 cm depth) - measurement of change in wound surface


Secondary Outcome Measures :
  1. Changes in wound morphology-exudate [ Time Frame: 6 weeks ]
    Evaluation of changes in the wound morphology measured by investigator's assessment of exudate.

  2. Changes in wound morphology-presence of redness [ Time Frame: 6 weeks ]
    Evaluation of changes in the wound morphology measured by investigator's assessment of presence of redness at the wound site.

  3. Changes in wound morphology-swelling [ Time Frame: 6 weeks ]
    Evaluation of changes in the wound morphology measured by investigator's assessment of swelling at the wound site.

  4. Changes in wound morphology-granulation tissue [ Time Frame: 6 weeks ]
    Evaluation of changes in the wound morphology measured by investigator's assessment of granulation tissue at the wound site.

  5. Record of adverse events [ Time Frame: 6 weeks ]
    Evaluation of safety of the method of cells' application assessed by adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signing informed consent form.
  2. Above the age of 18
  3. Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
  4. Chronic wound in the course of diabetic foot syndrome, with duration of at least 12 weeks and the wound surface not less than 2 sq. cm and not greater than 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
  5. Satisfactory blood glucose control - fasting not more than 110 mg%, HbA1c <6.5%
  6. Good tolerance of the current standard of treatment lasting at least one week before including the patient into the study
  7. Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (> 20mmHg) in patients with neuropathic etiology of diabetic foot syndrome
  8. In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb's blood supply as a result of the revascularization procedure documented by X-ray or ultrasound.
  9. Ankle-brachial index (ABI) ≥ 0.8
  10. No active infection of the wound and surrounding tissue verified by quantitative microbiological testing (105 bacteria per 1 g of tissue taken for testing from a wound)
  11. For women of childbearing potential - a negative pregnancy test result during the screening visit and using of effective contraceptive methods during participation in the research.

Exclusion Criteria:

  1. Lack of patient's cooperation
  2. Ischemia of lower limbs; ankle-brachial index <0.8; significant vein component in medical patient's history shown in the Duplex-Doppler tests made within 6 months before joining the research.
  3. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission had place less than 5 years before joining the study
  4. No clinical improvement after revascularization procedures performed on the vascular system of the treated limb during the last 2 weeks
  5. Venous thromboembolism in the past 3 months preceding participation in the research
  6. Sings of severe osteolysis and / or bone and marrow infection around wounds on the basis of the result of X-ray, CT or MRI of the feet made within 6 months before participation in the study.
  7. Charcot's foot
  8. Treatment with antibiotics, immunosuppressive therapy, including systemic steroid therapy (excluding inhaled medicines) at the time of joining the study.
  9. Chronic diseases in the stage of exacerbation, not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study and reviewed on the basis of subjective and objective examination and laboratory tests carried out during the screening visit (blood type, morphology, electrolytes, coagulation system, blood glucose, urea, creatinine, and viral tests). Test results behind laboratory standards for a specific parameter are considered as incorrect. In the case of treatment with vitamin K antagonists, normal ranges suitable for this treatment will apply.
  10. Known allergic reactions to ingredients of dressing (thrombin, penicillin).
  11. The diagnosis of AIDS, hepatitis B virus (HBV) or hepatitis C virus (HCV)
  12. Reactive result of serological and viral tests:

    • HIV-1 and 2 (HIV Ag / Ab);
    • Hepatitis B Virus Infection, Anti-hepatitis B core antigen (Anti-HBc) ;
    • Hepatitis C Virus Infection, Anti-HCV;
    • Syphilis specific tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865394


Contacts
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Contact: Malgorzata Lewandowska-Szumiel, Professor +48221166115 malgorzata.lewandowska-szumiel@wum.edu.pl

Locations
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Poland
Medical University of Warsaw, Department of General, Vascular and Transplant Surgery Recruiting
Warsaw, Poland
Sponsors and Collaborators
Medical University of Warsaw
Laboratory for Cell Research and Application, Medical University of Warsaw
Gen. Surgery, Vascular and Transplantation Dept., Medical University of Warsaw
Polish Stem Cells Bank S.A.
Investigators
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Principal Investigator: Sławomir D Nazarewski, Professor Medical University of Warsaw, Dept of General, Vascular and Transplant Surgery

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03865394     History of Changes
Other Study ID Numbers: 1ABC Therapy
267976/13/NCBR/2015 ( Other Grant/Funding Number: The National Center for Research and Development, Poland )
2016-004109-15 ( EudraCT Number )
PL008125 ( Other Identifier: EU tissue establishment code )
Z4217 ( Other Identifier: ISBT128 (Facility Identification Number) )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Warsaw:
stromal vascular fraction
adipose-derived mesenchymal stem cells
chronic wounds
diabetes
foot ulcer

Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases