Type I Diabetes Mellitus With UlcerPhase 1NCT01686139
Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers
A Phase 1 study testing ABMD-MSC in people with Type I Diabetes Mellitus With Ulcer and Type II Diabetes Mellitus With Ulcer, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Diabetes Mellitus (DM) can be regarded as one of the "epidemics" of the western world. DM contributes to severe morbidity and mortality due to damage in the target organs (neuropathy, vasculopathy, nephropathy, retinopathy). Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Type I Diabetes Mellitus With Ulcer, Type II Diabetes Mellitus With Ulcer
- What is being tested?
- ABMD-MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Dec 2017
- 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 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient signed informed consent.
- Adult males or females between 18 and 81 years of age with diabetes mellitus type 1 or type 2.
- Patient has one Diabetic Foot Ulcer (DFU) on the treated leg. The size of the DFU is no greater than 10 cm2 .
- The Diabetic Foot Ulcer (DFU) is neuropathic: The patient is checked by a 5.27 mm Monofilament, and doesn't have a sensation in at least 4 of 9 points in the foot.
- No endovascular or surgical interventions are planned.
- Patient isn't in an immediate life threat.
Show all 13Show fewer
- Normal organ and marrow function as defined:
- Leukocytes ≥3,000/μL
- Absolute neutrophil count ≥1,500/μL
- Platelets ≥140,000/μL
- AST (SGOT)/ALT (SGPT) ≤2.5 X institutional standards range
- Creatinine ≤ 2.5 mg/dL
- Patients with controlled blood pressure (defined as a systolic blood pressure ≤180 and/or a diastolic blood pressure of ≤110 mmHg) and established anti-hypertensive therapy as necessary prior to entry into the study.
Who cannot join
- Patient weight is greater than 120 Kg.
- Patients with poorly controlled diabetes mellitus (HbA1c > 10%).
- Presence of osteomyelitis (stage B grade 3 and stage D grade 3 on the UT Scale).
- More than one ulcer in the treated foot.
- Patients with a known failed ipsilateral revascularization procedure within 4 weeks prior to enrollment.
- Patients with ABI <= 0.3
Show all 26Show fewer
- Patients receiving treatment with hematopoietic growth factors.
- (Actively) infected ulcer.
- Infection of the involved extremity(ies) in the intended region of injection. Patient will be included (injected) if there is a safe zone of 10 cm from any soft tissue infection, manifested by fever, purulence and severe cellulitis.
- Active wet gangrenous tissue.
- Patients who require uninterrupted anticoagulation or anti-platelet therapy [i.e. anticoagulation therapy (e.g. Coumadin) that cannot be stopped for 72 hours prior to intramuscular injections.
- Patients with a blood clotting disorder not caused by medication.
- Patients with known cancer undergoing treatment including chemotherapy, radiotherapy or immunotherapy.
- Patients with end stage renal disease requiring dialysis.
- Patients who are pregnant or lactating.
- History of regular alcohol consumption exceeding 2 drinks/day (1 drink = 5 oz [150mL] of wine or 12 oz [360mL] of beer or 1.5 oz [45mL] of hard liquor) within 6 months of screening and/or history of illicit drug use.
- Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process.
- Patients receiving experimental medications or participating in another clinical study within 30 days of screening.
- Immune deficient patients.
- Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or Syphilis at the time of screening.
- Patients treated by Ilomedin (Iloprost).
- Patients having received a new chronic pharmacologic treatment regimen within 4 weeks prior to enrollment.
- Patients undergoing hyperbaric oxygen treatment within 4 weeks of inclusion and/or required throughout the trial.
- Concomitant wound treatments that include growth factors or tissue engineered products.
- In the opinion of the investigator, the patient is unsuitable for cellular therapy.
- Patients receiving systemic or direct target limb injection of antiangiogenic drugs.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center
Ramat Gan
Itzhak Siev-Ner, MD, 03-530-3701, zivner@netvision.net.il
Itzhak Siev-Ner, MD
About this study
Official title: Phase 1 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)
Diabetes Mellitus (DM) can be regarded as one of the "epidemics" of the western world.
DM contributes to severe morbidity and mortality due to damage in the target organs (neuropathy, vasculopathy, nephropathy, retinopathy).
Read more
It affects the quality of life of the patients because of increased rate of blindness, IHD, stroke, end stage renal failure, hemodialysis and lower limb amputations (LLA).The Diabetic Foot (DF) is defined as destruction or infection of tissue/s in the foot of diabetic patients due to neurological damage and / or different levels of Peripheral Vascular Disease (PVD). Diabetic foot complications are the most common cause of lower extremity amputations in the industrialized world. The lifetime occurence of Diabetic Foot Ulcers (DFU) is 20% in diabetic patients.
Between 15% - 25% of the foot ulcers will lead to lower limb amputations.
It has been shown that Mesenchymal Stem Cells (MSCs) could be an effective therapy for many diseases including acute respiratory distress syndrome, spinal cord injury, liver injury and critical limb ischemia.
Stem cells can be obtained from either the patient (autologous) or non-related healthy donors (allogeneic).
The purpose of this study is to determine the safety and efficacy of cultured Bone Marrow Mesenchymal Stromal Cells (BM-MSCs) from allogeneic donors for treatment of chronic leg wounds of diabetic patients.
- Being tested
- ABMD-MSC
- Keywords
- Diabetic mellitus, Diabetic foot ulcers, Ischemic Limb
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABMD-MSCBiological
10-20 x 10^6 cells/20mL
| Study group | Role | What they receive |
|---|---|---|
| ABDM-MSC | Experimental | The patient will receive multiple injections in one session during the study. The injections will take place in the chronic wound bed and in the third distal part of the treated shin (in the form of a ring).
Maximal amount of ABMD-MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size \& patient weight). Receives: Biological: ABMD-MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Frequency and severity of Adverse Events.
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2012 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Type I Diabetes Mellitus With UlcerStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Itzhak Siev-Ner, Sheba Medical Center
- Investigators
- Itzhak Siev-Ner, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686139
- Sponsor's protocol ID
- SHEBA-11-8802-IS-SMC
- Status last verified
- Jan 2016
- First submitted
- 12 Sep 2012
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Friedenstein AJ, Gorskaja JF, Kulagina NN. Fibroblast precursors in normal and irradiated mouse hematopoietic organs. Exp Hematol. 1976 Sep;4(5):267-74.
PubMed 976387Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.
PubMed 19926330Wu Y, Zhao RC, Tredget EE. Concise review: bone marrow-derived stem/progenitor cells in cutaneous repair and regeneration. Stem Cells. 2010 May;28(5):905-15. doi: 10.1002/stem.420.
PubMed 20474078Sensebe L, Krampera M, Schrezenmeier H, Bourin P, Giordano R. Mesenchymal stem cells for clinical application. Vox Sang. 2010 Feb;98(2):93-107. doi: 10.1111/j.1423-0410.2009.01227.x. Epub 2009 Aug 3.
PubMed 19663934Chen L, Tredget EE, Wu PY, Wu Y. Paracrine factors of mesenchymal stem cells recruit macrophages and endothelial lineage cells and enhance wound healing. PLoS One. 2008 Apr 2;3(4):e1886. doi: 10.1371/journal.pone.0001886.
PubMed 18382669Fu X, Fang L, Li X, Cheng B, Sheng Z. Enhanced wound-healing quality with bone marrow mesenchymal stem cells autografting after skin injury. Wound Repair Regen. 2006 May-Jun;14(3):325-35. doi: 10.1111/j.1743-6109.2006.00128.x.
PubMed 16808812McFarlin K, Gao X, Liu YB, Dulchavsky DS, Kwon D, Arbab AS, Bansal M, Li Y, Chopp M, Dulchavsky SA, Gautam SC. Bone marrow-derived mesenchymal stromal cells accelerate wound healing in the rat. Wound Repair Regen. 2006 Jul-Aug;14(4):471-8. doi: 10.1111/j.1743-6109.2006.00153.x.
PubMed 16939576Wu Y, Wang J, Scott PG, Tredget EE. Bone marrow-derived stem cells in wound healing: a review. Wound Repair Regen. 2007 Sep-Oct;15 Suppl 1:S18-26. doi: 10.1111/j.1524-475X.2007.00221.x.
PubMed 17727462Kwon DS, Gao X, Liu YB, Dulchavsky DS, Danyluk AL, Bansal M, Chopp M, McIntosh K, Arbab AS, Dulchavsky SA, Gautam SC. Treatment with bone marrow-derived stromal cells accelerates wound healing in diabetic rats. Int Wound J. 2008 Jun;5(3):453-63. doi: 10.1111/j.1742-481X.2007.00408.x.
PubMed 18593394Brem H, Tomic-Canic M. Cellular and molecular basis of wound healing in diabetes. J Clin Invest. 2007 May;117(5):1219-22. doi: 10.1172/JCI32169.
PubMed 17476353Iwase T, Nagaya N, Fujii T, Itoh T, Murakami S, Matsumoto T, Kangawa K, Kitamura S. Comparison of angiogenic potency between mesenchymal stem cells and mononuclear cells in a rat model of hindlimb ischemia. Cardiovasc Res. 2005 Jun 1;66(3):543-51. doi: 10.1016/j.cardiores.2005.02.006. Epub 2005 Mar 2.
PubMed 15914119Rafii S, Lyden D. Therapeutic stem and progenitor cell transplantation for organ vascularization and regeneration. Nat Med. 2003 Jun;9(6):702-12. doi: 10.1038/nm0603-702.
PubMed 12778169Falanga V, Iwamoto S, Chartier M, Yufit T, Butmarc J, Kouttab N, Shrayer D, Carson P. Autologous bone marrow-derived cultured mesenchymal stem cells delivered in a fibrin spray accelerate healing in murine and human cutaneous wounds. Tissue Eng. 2007 Jun;13(6):1299-312. doi: 10.1089/ten.2006.0278.
PubMed 17518741Kirana S, Stratmann B, Lammers D, Negrean M, Stirban A, Minartz P, Koerperich H, Gastens MH, Gotting C, Prohaska W, Kleesiek K, Tschoepe D. Wound therapy with autologous bone marrow stem cells in diabetic patients with ischaemia-induced tissue ulcers affecting the lower limbs. Int J Clin Pract. 2007 Apr;61(4):690-2. doi: 10.1111/j.1742-1241.2007.01303.x.
PubMed 17394441Dash NR, Dash SN, Routray P, Mohapatra S, Mohapatra PC. Targeting nonhealing ulcers of lower extremity in human through autologous bone marrow-derived mesenchymal stem cells. Rejuvenation Res. 2009 Oct;12(5):359-66. doi: 10.1089/rej.2009.0872.
PubMed 19929258
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)
- ClinicalTrials.gov ID
- NCT01686139
- Acronym / sponsor ID
- SHEBA-11-8802-IS-SMC
- Keywords
- Diabetic mellitus, Diabetic foot ulcers, Ischemic Limb
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Sep 2012 (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.
Diabetes Mellitus (DM) can be regarded as one of the "epidemics" of the western world.
DM contributes to severe morbidity and mortality due to damage in the target organs (neuropathy, vasculopathy, nephropathy, retinopathy).
It affects the quality of life of the patients because of increased rate of blindness, IHD, stroke, end stage renal failure, hemodialysis and lower limb amputations (LLA).The Diabetic Foot (DF) is defined as destruction or infection of tissue/s in the foot of diabetic patients due to neurological damage and / or different levels of Peripheral Vascular Disease (PVD). Diabetic foot complications are the most common cause of lower extremity amputations in the industrialized world. The lifetime occurence of Diabetic Foot Ulcers (DFU) is 20% in diabetic patients.
Between 15% - 25% of the foot ulcers will lead to lower limb amputations.
It has been shown that Mesenchymal Stem Cells (MSCs) could be an effective therapy for many diseases including acute respiratory distress syndrome, spinal cord injury, liver injury and critical limb ischemia.
Stem cells can be obtained from either the patient (autologous) or non-related healthy donors (allogeneic).
The purpose of this study is to determine the safety and efficacy of cultured Bone Marrow Mesenchymal Stromal Cells (BM-MSCs) from allogeneic donors for treatment of chronic leg wounds of diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABDM-MSC | Experimental | Biological: ABMD-MSCThe patient will receive multiple injections in one session during the study. The injections will take place in the chronic wound bed and in the third distal part of the treated shin (in the form of a ring). Maximal amount of ABMD-MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size \& patient weight). |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient signed informed consent.
- Adult males or females between 18 and 81 years of age with diabetes mellitus type 1 or type 2.
- Patient has one Diabetic Foot Ulcer (DFU) on the treated leg. The size of the DFU is no greater than 10 cm2 .
- The Diabetic Foot Ulcer (DFU) is neuropathic: The patient is checked by a 5.27 mm Monofilament, and doesn't have a sensation in at least 4 of 9 points in the foot.
- No endovascular or surgical interventions are planned.
Key exclusion criteria (26 listed)
- Patient weight is greater than 120 Kg.
- Patients with poorly controlled diabetes mellitus (HbA1c > 10%).
- Presence of osteomyelitis (stage B grade 3 and stage D grade 3 on the UT Scale).
- More than one ulcer in the treated foot.
- Patients with a known failed ipsilateral revascularization procedure within 4 weeks prior to enrollment.
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 |
|---|---|---|
| ABMD-MSC10-20 x 10^6 cells/20mL | Biological | ABDM-MSC |
Primary outcome
Frequency of Adverse Events
Time frame: 6 months after treatment
Frequency and severity of Adverse Events.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Background: PubMed 976387Friedenstein AJ, Gorskaja JF, Kulagina NN. Fibroblast precursors in normal and irradiated mouse hematopoietic organs. Exp Hematol. 1976 Sep;4(5):267-74.
- Background: PubMed 19926330Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.
- Background: PubMed 20474078Wu Y, Zhao RC, Tredget EE. Concise review: bone marrow-derived stem/progenitor cells in cutaneous repair and regeneration. Stem Cells. 2010 May;28(5):905-15. doi: 10.1002/stem.420.
- Background: PubMed 19663934Sensebe L, Krampera M, Schrezenmeier H, Bourin P, Giordano R. Mesenchymal stem cells for clinical application. Vox Sang. 2010 Feb;98(2):93-107. doi: 10.1111/j.1423-0410.2009.01227.x. Epub 2009 Aug 3.
- Background: PubMed 18382669Chen L, Tredget EE, Wu PY, Wu Y. Paracrine factors of mesenchymal stem cells recruit macrophages and endothelial lineage cells and enhance wound healing. PLoS One. 2008 Apr 2;3(4):e1886. doi: 10.1371/journal.pone.0001886.
- Background: PubMed 16808812Fu X, Fang L, Li X, Cheng B, Sheng Z. Enhanced wound-healing quality with bone marrow mesenchymal stem cells autografting after skin injury. Wound Repair Regen. 2006 May-Jun;14(3):325-35. doi: 10.1111/j.1743-6109.2006.00128.x.
- Background: PubMed 16939576McFarlin K, Gao X, Liu YB, Dulchavsky DS, Kwon D, Arbab AS, Bansal M, Li Y, Chopp M, Dulchavsky SA, Gautam SC. Bone marrow-derived mesenchymal stromal cells accelerate wound healing in the rat. Wound Repair Regen. 2006 Jul-Aug;14(4):471-8. doi: 10.1111/j.1743-6109.2006.00153.x.
- Background: PubMed 17727462Wu Y, Wang J, Scott PG, Tredget EE. Bone marrow-derived stem cells in wound healing: a review. Wound Repair Regen. 2007 Sep-Oct;15 Suppl 1:S18-26. doi: 10.1111/j.1524-475X.2007.00221.x.
- Background: PubMed 18593394Kwon DS, Gao X, Liu YB, Dulchavsky DS, Danyluk AL, Bansal M, Chopp M, McIntosh K, Arbab AS, Dulchavsky SA, Gautam SC. Treatment with bone marrow-derived stromal cells accelerates wound healing in diabetic rats. Int Wound J. 2008 Jun;5(3):453-63. doi: 10.1111/j.1742-481X.2007.00408.x.
- Background: PubMed 17476353Brem H, Tomic-Canic M. Cellular and molecular basis of wound healing in diabetes. J Clin Invest. 2007 May;117(5):1219-22. doi: 10.1172/JCI32169.
- Background: PubMed 15914119Iwase T, Nagaya N, Fujii T, Itoh T, Murakami S, Matsumoto T, Kangawa K, Kitamura S. Comparison of angiogenic potency between mesenchymal stem cells and mononuclear cells in a rat model of hindlimb ischemia. Cardiovasc Res. 2005 Jun 1;66(3):543-51. doi: 10.1016/j.cardiores.2005.02.006. Epub 2005 Mar 2.
- Background: PubMed 12778169Rafii S, Lyden D. Therapeutic stem and progenitor cell transplantation for organ vascularization and regeneration. Nat Med. 2003 Jun;9(6):702-12. doi: 10.1038/nm0603-702.
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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.
Itzhak Siev-Ner, MD principal investigator
Sheba Medical Center
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 ABMD-MSC in people with Type I Diabetes Mellitus With Ulcer and Type II Diabetes Mellitus With Ulcer, run by Sheba Medical Center at 1 site 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 13 inclusion and 26 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 27 Jan 2016. 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 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.
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 Itzhak Siev-Ner, MD (03-530-3701, zivner@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (time frame: 6 months after treatment). 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 NCT01686139, which also lists 30 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 27 Jan 2016.