Peripheral Vascular DiseasePhase 2/3BONMOTNCT00434616
Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia
A Phase 2/3 study testing Autologous bone marrow cell concentrate transplantation and saline injection in people with Peripheral Vascular Disease and Diabetic Foot, run by Franziskus-Krankenhaus at 1 site in Germany.
Trial summary
Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arteriosclerosis and/or diabetes. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Peripheral Vascular Disease, Diabetic Foot, Peripheral Arterial Occlusive Disease
- What is being tested?
- Autologous bone marrow cell concentrate transplantation and saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Jul 2011
- Phase
- Phase 2/3
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of Critical Limb ischemia according to the guidelines of the Transatlantic Consensus Group (TASC) Rutherford grade II or III. Perfusion is measured with absolute perfusion pressure and ankle-brachial index (ABI) and transcutaneous oxygen tension (TcpO2); for inclusion, ABI has to be less than or equal to 0.6 or absolute ankle pressure must be less than 60 mmHg. If ABI is technically not feasible, e.g. in patients with media calcification, inclusion criteria are a tcpO2 value (supine, forefoot, 44°C) of less than 20 mmHg if there is no tissue loss, or a tcpO2 of less than 40 mmHg if there is tissue loss.
- No sufficient response to best standard care delivered for six weeks.
- No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
- Age older than 18 years
- Signed informed consent
- Absence of life-threatening complications from the ischemic limb
Who cannot join
- Expected life span less than six months
- Bone marrow diseases which preclude transplantation (eg lymphoma, leukaemia, myelodysplastic syndrome and others)
- Renal failure on hemodialysis
- Life threatening complications of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
Trial locations and contacts
1 site in 1 country.
Germany1 site
Franziskus Hospital Berlin Vascular Center
Berlin, State of Berlin, D 10787
About this study
Official title: Security and Effectiveness of Autologous Bone Marrow Stem Cell Transplantation to Avoid Amputations in Patients With Limb-threatening Ischemia: A Multicentric Randomized Placebo-controlled Double-blind Study
Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arteriosclerosis and/or diabetes. If surgical and other methods for the improvement of blood supply for the leg have failed or are not possible, most of these patients will proceed to amputation of the leg.
Bone marrow contains cells which can induce and augment the growth of new, small arteries called collateral arteries. It has been shown in animals and in some case series that the transplantation of a concentrate of the patient's own bone marrow with stem cells into the ischemic limb can improve the blood circulation via the induction of collateral growth. However, it is not known if this bone-marrow stem cell induced collateral growth is sufficient to avoid otherwise necessary amputations.
Read more
Therefore, we conduct a study to compare the efficiency of concentrated bone marrow cells injected into the critically ischemic limb compared to a placebo procedure where only saline is injected. We think that the transplantation of autologous bone marrow will reduce the number of necessary leg amputations, reduce pain and induce wound healing. In this investigation, patients with limb threatening ischemia are randomly allocated either to the bone marrow group or to the placebo group. Patients in the bone marrow group will have their bone marrow harvested under sedation, and the bone marrow cells are concentrated. The cell concentrate will then be injected directly into the muscle of the diseased leg. Patients in the placebo group will undergo sedation as well but no bone marrow harvest is done, and saline is injected into the ischemic leg. The procedure will require about 1.5-2 hours, and the subjects will be admitted to a participating vascular Centre. Monthly examinations up to three months after the bone-marrow or placebo procedure are done. After the follow-up of three months, the rate of death and amputations and the wound healing process are compared between groups. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include skin oxygen measurements, pressure recordings in the leg and arteriography. Also, quality of life, pain and wound healing will be assessed.
After completion of the three months study participation, subjects who have been treated with placebo will be able to receive open-label bone marrow transplantation therapy.
Read the detailed description
Peripheral arterial disease (PAD) represents very advanced arteriosclerosis. It is not unusual for this condition to result in limb-threatening ischemia that usually results in amputation of the limb. About 150.000 thigh or calf amputations due to PAD are done annually in the United states.
Treatment of critical limb threatening ischemia (corresponding to Rutherford grade II or III) consists of revascularization of the leg with critically reduced blood supply. Depending on the localization and morphology of the occlusion, surgical revascularization by means of bypass surgery or catheter-based percutaneous transluminal angioplasty (PTA) may be used (even as a complementary procedure). However, successful revascularization is possible in only max. 60% to 70% of the patients affected. Patients with limb threatening ischemia which cannot be revascularized have a one-year amputation rate exceeding 80% and a 20-30% mortality.
Several studies have shown that in less advanced PAD the implantation of a concentration of mononuclear cells harvested from the patient's own bone marrow has been effective in developing collateral vessel formation translating into an improvement in PAD symptoms. Additional clinical evidence that this simple, safe and inexpensive therapy can induce therapeutic angiogenesis in the ischemic limb sufficient to prevent amputation would be valuable to both patients and clinicians.
This study will evaluate the clinical potential for the implantation of a concentration of bone marrow mononuclear cells which contain stem cells for therapeutic angiogenesis through the augmented formation of collateral vessels in the ischemic limb. It is a placebo-controlled, 1:1 randomized study with a total of 90 patients included. The placebo procedure consists of a sham bone marrow puncture where no bone marrow aspiration is done; instead, only a stab puncture of the skin is made.
The bone marrow cell concentrate will be prepared "point of care", patient-side from an aspirate of 240 mL of bone marrow. A concentrate volume of 40-50 mL will be injected into 40-50 sites in the muscles of the ischemic limb. A blinded physician injects either the bone marrow cell concentrate or the visually identical placebo solution into the ischemic leg.
Improvement in perfusion of the limb will be measured using clinical assessment and ankle-brachial-index (ABI), transcutaneous oxygen (TcPO2) and contrast angiography. Quality of life and pain will be assessed.
Study participation ends for the subjects after a follow-up of three months with monthly visits. After this, clinical and perfusion status are recorded at least three-monthly up to two years after study inclusion.
HYPOTHESIS:
Implantation of Bone Marrow stem cell Aspirate Concentrate (BMAC) can be clinically effective in treating critical limb threatening ischemia so that the number of amputations can be reduced.
Inclusion criteria:
- Presence of Critical Limb ischemia according to the guidelines of the Transatlantic Consensus Group (TASC) Rutherford grade II or III. Perfusion is measured with absolute perfusion pressure and ankle-brachial index (ABI) and transcutaneous oxygen tension (TcpO2); for inclusion, ABI has to be less than or equal to 0.6 or absolute ankle pressure must be less than 60 mmHg. If ABI is technically not feasible, e.g. in patients with media calcification, inclusion criteria are a tcpO2 value (supine, forefoot, 44°C) of less than 20 mmHg if there is no tissue loss, or a tcpO2 of less than 40 mmHg if there is tissue loss.
- No sufficient response to best standard care delivered for six weeks.
- No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
- Age older than 18 years
- Signed informed consent
- Absence of life-threatening complications from the ischemic limb
Exclusion criteria:
- Expected life span less than six months
- Bone marrow diseases which preclude transplantation (eg lymphoma, leukemia, myelodysplastic syndrome and others)
- Renal failure on hemodialysis
- Life threatening complications of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
End points:
- Primary end point: Major amputation (above the ankle) of the index limb after 3 months or persisting critical limb ischemia of the index limb after three months
- Secondary end points:
- Wound healing (wound size, wound stage)
- Pain and analgesics use
- Rutherford grade and stage
- Walking distance (treadmill) if possible
- Quality of life (EQ-5D Questionnaire)
- Transcutaneous oxygen pressure (TcpO2), ABI, absolute ankle perfusion pressure
- Collateral artery number as judged by contrast angiography after 3 months
- Rate and extent of minor (below the ankle) amputations in the index limb
- Conditions
- Peripheral Vascular Disease, Diabetic Foot, Peripheral Arterial Occlusive Disease, Leg Ulcer, Gangrene, Ischemia
- Being tested
- Autologous bone marrow cell concentrate transplantation, saline injection
- Keywords
- angiogenesis, Arterial Occlusive Diseases, Leg Ulcer, Gangrene, Ischemia, PAOD, Amputation, bone marrow
- Medical subject headings
- Peripheral Vascular Diseases, Diabetic Foot, Peripheral Arterial Occlusive Disease 1, Leg Ulcer, Gangrene, Ischemia, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow cell concentrate transplantationProcedure or surgery
bone marrow aspiration (240 ml), processing and reinjection
saline injectionBiological
saline injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | saline injections Receives: Biological: saline injection |
| 2 | Active comparator | autologous bone marrow transplantation into the ischemic leg Receives: Procedure: Autologous bone marrow cell concentrate transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major amputation of the index limb or persisting, unchanged critical limb ischemia
Measured: 3 months
Secondary outcomes (9)
Wound healing (wound size, wound stage)
Measured: 3 months
Pain and analgesics use
Measured: 3 months
Rutherford grade and stage
Measured: 3 months
Walking distance (treadmill) if possible
Measured: 3 months
Quality of life (EQ-5D Questionnaire)
Measured: 3 months
Transcutaneous oxygen pressure (TcpO2), ABI, absolute ankle perfusion pressure
Measured: 3 months
Collateral artery number as judged by contrast angiography after 3 months
Measured: 3 months
Rate and extent of minor (below the ankle) amputations
Measured: 3 months
survival without amputation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2011
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franziskus-Krankenhaus
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Karlsbad-Langensteinbach, Stiftungsklinikum Boppard, Krankenhaus der Barmherzigen Brüder Trier
- Investigators
- Berthold Amann, MD, Principal investigator, Franziskus Hospital, Berlin Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434616
- Sponsor's protocol ID
- 2006-001825-24
- Other IDs
- FKH 200
- Acronym
- BONMOT
- Status last verified
- Apr 2011
- First submitted
- 9 Feb 2007
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
PubMed 12241713Durdu S, Akar AR, Arat M, Sancak T, Eren NT, Ozyurda U. Autologous bone-marrow mononuclear cell implantation for patients with Rutherford grade II-III thromboangiitis obliterans. J Vasc Surg. 2006 Oct;44(4):732-9. doi: 10.1016/j.jvs.2006.06.023. Epub 2006 Aug 22.
PubMed 16926085Iba O, Matsubara H, Nozawa Y, Fujiyama S, Amano K, Mori Y, Kojima H, Iwasaka T. Angiogenesis by implantation of peripheral blood mononuclear cells and platelets into ischemic limbs. Circulation. 2002 Oct 8;106(15):2019-25. doi: 10.1161/01.cir.0000031332.45480.79.
PubMed 12370229Nizankowski R, Petriczek T, Skotnicki A, Szczeklik A. The treatment of advanced chronic lower limb ischaemia with marrow stem cell autotransplantation. Kardiol Pol. 2005 Oct;63(4):351-60; discussion 361. English, Polish.
PubMed 16273471Hernandez P, Cortina L, Artaza H, Pol N, Lam RM, Dorticos E, Macias C, Hernandez C, del Valle L, Blanco A, Martinez A, Diaz F. Autologous bone-marrow mononuclear cell implantation in patients with severe lower limb ischaemia: a comparison of using blood cell separator and Ficoll density gradient centrifugation. Atherosclerosis. 2007 Oct;194(2):e52-6. doi: 10.1016/j.atherosclerosis.2006.08.025. Epub 2006 Sep 18.
PubMed 16982058Lawall H, Bramlage P, Amann B. Stem cell and progenitor cell therapy in peripheral artery disease. A critical appraisal. Thromb Haemost. 2010 Apr;103(4):696-709. doi: 10.1160/TH09-10-0688. Epub 2010 Feb 19.
PubMed 20174766Amann B, Luedemann C, Ratei R, Schmidt-Lucke JA. Autologous bone marrow cell transplantation increases leg perfusion and reduces amputations in patients with advanced critical limb ischemia due to peripheral artery disease. Cell Transplant. 2009;18(3):371-80. doi: 10.3727/096368909788534942. Epub 2009 Apr 2.
PubMed 19500466
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Security and Effectiveness of Autologous Bone Marrow Stem Cell Transplantation to Avoid Amputations in Patients With Limb-threatening Ischemia: A Multicentric Randomized Placebo-controlled Double-blind Study
- ClinicalTrials.gov ID
- NCT00434616
- Acronym / sponsor ID
- BONMOT / 2006-001825-24
- Conditions
- Peripheral Vascular Disease, Diabetic Foot, Peripheral Arterial Occlusive Disease, Leg Ulcer, Gangrene, Ischemia
- Keywords
- angiogenesis, Arterial Occlusive Diseases, Leg Ulcer, Gangrene, Ischemia, PAOD, Amputation, bone marrow
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Franziskus-KrankenhausUniversity, hospital or other
- Collaborators
- Klinikum Karlsbad-Langensteinbach, Stiftungsklinikum Boppard, Krankenhaus der Barmherzigen Brüder Trier
- Study start
- Apr 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 13 Feb 2007 (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.
Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arteriosclerosis and/or diabetes. If surgical and other methods for the improvement of blood supply for the leg have failed or are not possible, most of these patients will proceed to amputation of the leg.
Bone marrow contains cells which can induce and augment the growth of new, small arteries called collateral arteries. It has been shown in animals and in some case series that the transplantation of a concentrate of the patient's own bone marrow with stem cells into the ischemic limb can improve the blood circulation via the induction of collateral growth. However, it is not known if this bone-marrow stem cell induced collateral growth is sufficient to avoid otherwise necessary amputations.
Therefore, we conduct a study to compare the efficiency of concentrated bone marrow cells injected into the critically ischemic limb compared to a placebo procedure where only saline is injected. We think that the transplantation of autologous bone marrow will reduce the number of necessary leg amputations, reduce pain and induce wound healing. In this investigation, patients with limb threatening ischemia are randomly allocated either to the bone marrow group or to the placebo group. Patients in the bone marrow group will have their bone marrow harvested under sedation, and the bone marrow cells are concentrated. The cell concentrate will then be injected directly into the muscle of the diseased leg. Patients in the placebo group will undergo sedation as well but no bone marrow harvest is done, and saline is injected into the ischemic leg. The procedure will require about 1.5-2 hours, and the subjects will be admitted to a participating vascular Centre. Monthly examinations up to three months after the bone-marrow or placebo procedure are done. After the follow-up of three months, the rate of death and amputations and the wound healing process are compared between groups. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include skin oxygen measurements, pressure recordings in the leg and arteriography. Also, quality of life, pain and wound healing will be assessed.
After completion of the three months study participation, subjects who have been treated with placebo will be able to receive open-label bone marrow transplantation therapy.
Detailed description
Peripheral arterial disease (PAD) represents very advanced arteriosclerosis. It is not unusual for this condition to result in limb-threatening ischemia that usually results in amputation of the limb. About 150.000 thigh or calf amputations due to PAD are done annually in the United states.
Treatment of critical limb threatening ischemia (corresponding to Rutherford grade II or III) consists of revascularization of the leg with critically reduced blood supply. Depending on the localization and morphology of the occlusion, surgical revascularization by means of bypass surgery or catheter-based percutaneous transluminal angioplasty (PTA) may be used (even as a complementary procedure). However, successful revascularization is possible in only max. 60% to 70% of the patients affected. Patients with limb threatening ischemia which cannot be revascularized have a one-year amputation rate exceeding 80% and a 20-30% mortality.
Several studies have shown that in less advanced PAD the implantation of a concentration of mononuclear cells harvested from the patient's own bone marrow has been effective in developing collateral vessel formation translating into an improvement in PAD symptoms. Additional clinical evidence that this simple, safe and inexpensive therapy can induce therapeutic angiogenesis in the ischemic limb sufficient to prevent amputation would be valuable to both patients and clinicians.
This study will evaluate the clinical potential for the implantation of a concentration of bone marrow mononuclear cells which contain stem cells for therapeutic angiogenesis through the augmented formation of collateral vessels in the ischemic limb. It is a placebo-controlled, 1:1 randomized study with a total of 90 patients included. The placebo procedure consists of a sham bone marrow puncture where no bone marrow aspiration is done; instead, only a stab puncture of the skin is made.
The bone marrow cell concentrate will be prepared "point of care", patient-side from an aspirate of 240 mL of bone marrow. A concentrate volume of 40-50 mL will be injected into 40-50 sites in the muscles of the ischemic limb. A blinded physician injects either the bone marrow cell concentrate or the visually identical placebo solution into the ischemic leg.
Improvement in perfusion of the limb will be measured using clinical assessment and ankle-brachial-index (ABI), transcutaneous oxygen (TcPO2) and contrast angiography. Quality of life and pain will be assessed.
Study participation ends for the subjects after a follow-up of three months with monthly visits. After this, clinical and perfusion status are recorded at least three-monthly up to two years after study inclusion.
HYPOTHESIS:
Implantation of Bone Marrow stem cell Aspirate Concentrate (BMAC) can be clinically effective in treating critical limb threatening ischemia so that the number of amputations can be reduced.
Inclusion criteria:
- Presence of Critical Limb ischemia according to the guidelines of the Transatlantic Consensus Group (TASC) Rutherford grade II or III. Perfusion is measured with absolute perfusion pressure and ankle-brachial index (ABI) and transcutaneous oxygen tension (TcpO2); for inclusion, ABI has to be less than or equal to 0.6 or absolute ankle pressure must be less than 60 mmHg. If ABI is technically not feasible, e.g. in patients with media calcification, inclusion criteria are a tcpO2 value (supine, forefoot, 44°C) of less than 20 mmHg if there is no tissue loss, or a tcpO2 of less than 40 mmHg if there is tissue loss.
- No sufficient response to best standard care delivered for six weeks.
- No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
- Age older than 18 years
- Signed informed consent
- Absence of life-threatening complications from the ischemic limb
Exclusion criteria:
- Expected life span less than six months
- Bone marrow diseases which preclude transplantation (eg lymphoma, leukemia, myelodysplastic syndrome and others)
- Renal failure on hemodialysis
- Life threatening complications of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
End points:
- Primary end point: Major amputation (above the ankle) of the index limb after 3 months or persisting critical limb ischemia of the index limb after three months
- Secondary end points:
- Wound healing (wound size, wound stage)
- Pain and analgesics use
- Rutherford grade and stage
- Walking distance (treadmill) if possible
- Quality of life (EQ-5D Questionnaire)
- Transcutaneous oxygen pressure (TcpO2), ABI, absolute ankle perfusion pressure
- Collateral artery number as judged by contrast angiography after 3 months
- Rate and extent of minor (below the ankle) amputations in the index limb
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Biological: saline injectionsaline injections |
| 2 | Active comparator | Procedure: Autologous bone marrow cell concentrate transplantationautologous bone marrow transplantation into the ischemic leg |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of Critical Limb ischemia according to the guidelines of the Transatlantic Consensus Group (TASC) Rutherford grade II or III. Perfusion is measured with absolute perfusion pressure and ankle-brachial index (ABI) and transcutaneous oxygen tension (TcpO2); for inclusion, ABI has to be less than or equal to 0.6 or absolute ankle pressure must be less than 60 mmHg. If ABI is technically not feasible, e.g. in patients with media calcification, inclusion criteria are a tcpO2 value (supine, forefoot, 44°C) of less than 20 mmHg if there is no tissue loss, or a tcpO2 of less than 40 mmHg if there is tissue loss.
- No sufficient response to best standard care delivered for six weeks.
- No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
- Age older than 18 years
- Signed informed consent
Key exclusion criteria (4 listed)
- Expected life span less than six months
- Bone marrow diseases which preclude transplantation (eg lymphoma, leukaemia, myelodysplastic syndrome and others)
- Renal failure on hemodialysis
- Life threatening complications of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
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 |
|---|---|---|
| Autologous bone marrow cell concentrate transplantationbone marrow aspiration (240 ml), processing and reinjection | Procedure or surgery | 2 |
| saline injectionsaline injections | Biological | 1 |
Primary outcome
Major amputation of the index limb or persisting, unchanged critical limb ischemia
Time frame: 3 months
9 secondary outcomes
Wound healing (wound size, wound stage)
Time frame: 3 months
Pain and analgesics use
Time frame: 3 months
Rutherford grade and stage
Time frame: 3 months
Walking distance (treadmill) if possible
Time frame: 3 months
Quality of life (EQ-5D Questionnaire)
Time frame: 3 months
Transcutaneous oxygen pressure (TcpO2), ABI, absolute ankle perfusion pressure
Time frame: 3 months
Collateral artery number as judged by contrast angiography after 3 months
Time frame: 3 months
Rate and extent of minor (below the ankle) amputations
Time frame: 3 months
survival without amputation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
- Background: PubMed 12241713Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
- Background: PubMed 16926085Durdu S, Akar AR, Arat M, Sancak T, Eren NT, Ozyurda U. Autologous bone-marrow mononuclear cell implantation for patients with Rutherford grade II-III thromboangiitis obliterans. J Vasc Surg. 2006 Oct;44(4):732-9. doi: 10.1016/j.jvs.2006.06.023. Epub 2006 Aug 22.
- Background: PubMed 12370229Iba O, Matsubara H, Nozawa Y, Fujiyama S, Amano K, Mori Y, Kojima H, Iwasaka T. Angiogenesis by implantation of peripheral blood mononuclear cells and platelets into ischemic limbs. Circulation. 2002 Oct 8;106(15):2019-25. doi: 10.1161/01.cir.0000031332.45480.79.
- Background: PubMed 16273471Nizankowski R, Petriczek T, Skotnicki A, Szczeklik A. The treatment of advanced chronic lower limb ischaemia with marrow stem cell autotransplantation. Kardiol Pol. 2005 Oct;63(4):351-60; discussion 361. English, Polish.
- Background: PubMed 16982058Hernandez P, Cortina L, Artaza H, Pol N, Lam RM, Dorticos E, Macias C, Hernandez C, del Valle L, Blanco A, Martinez A, Diaz F. Autologous bone-marrow mononuclear cell implantation in patients with severe lower limb ischaemia: a comparison of using blood cell separator and Ficoll density gradient centrifugation. Atherosclerosis. 2007 Oct;194(2):e52-6. doi: 10.1016/j.atherosclerosis.2006.08.025. Epub 2006 Sep 18.
- Background: PubMed 20174766Lawall H, Bramlage P, Amann B. Stem cell and progenitor cell therapy in peripheral artery disease. A critical appraisal. Thromb Haemost. 2010 Apr;103(4):696-709. doi: 10.1160/TH09-10-0688. Epub 2010 Feb 19.
- Background: PubMed 19500466Amann B, Luedemann C, Ratei R, Schmidt-Lucke JA. Autologous bone marrow cell transplantation increases leg perfusion and reduces amputations in patients with advanced critical limb ischemia due to peripheral artery disease. Cell Transplant. 2009;18(3):371-80. doi: 10.3727/096368909788534942. Epub 2009 Apr 2.
- Home page of Berlin Vascular CenterLink provided by the sponsor.
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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.
Berthold Amann, MD principal investigator
Franziskus Hospital, Berlin Vascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous bone marrow cell concentrate transplantation and saline injection in people with Peripheral Vascular Disease and Diabetic Foot, run by Franziskus-Krankenhaus at 1 site in Germany.
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 6 inclusion and 4 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 6 Apr 2011. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Major amputation of the index limb or persisting, unchanged critical limb ischemia (time frame: 3 months). 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 NCT00434616, which also lists 7 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 6 Apr 2011.