Critical Limb IschemiaPhase 2MESENDONCT00721006
Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
A Phase 2 study testing MESENDO in people with Critical Limb Ischemia and Severe Leg Ischemia, run by TCA Cellular Therapy at 1 site in United States.
Trial summary
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Critical Limb Ischemia, Severe Leg Ischemia, Peripheral Artery Disease
- What is being tested?
- MESENDO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2010
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females older than 18 years of age.
- Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart.
- Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers.
- Claudication
- Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia.
Who cannot join
- Inability to provide informed consent.
- Previous angiogenic therapy.
- Known sensitivity to gentamycin and/or amphotericin B.
- Use or expected use of antineoplastic drugs.
- Any illness, which might affect the patient's survival after enrollment in the protocol.
- Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results.
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- No evidence of acute infection
- WBC > 15000.
- WBC < 4000.
- Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis.
- Pregnant women or women planning to become pregnant or unwilling to use appropriate birth control methods before and 2 months after cell infusion.
- Recent myocardial infarction within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Safety/Efficacy Study of A Combination Stem Cell Therapy That Develops Mature Stable Vessel Formation in Ischemic Limbs
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.
Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.
Read more
LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.
In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.
Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.
Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.
- Conditions
- Critical Limb Ischemia, Severe Leg Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease
- Being tested
- MESENDO, Placebo
- Keywords
- peripheral artery disease, peripheral vascular disease, PAD, PVD
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESENDOBiological
40 subcutaneous injections of biological product
PlaceboBiological
40 subcutaneous injections of placebo
| Study group | Role | What they receive |
|---|---|---|
| MESENDO | Experimental | All subjects will receive active treatment in a blinded fashion in the left or right lower limb. The opposite lower limb will receive placebo. Receives: Biological: MESENDO |
| placebo | Placebo comparator | All subjects will receive placebo injections in a blinded fashion in the left or right lower limb. The opposite lower limb will receive active stem cell infusion Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia.
Measured: 4 months
Secondary outcomes (1)
Changes in resting leg pain identified by a Visual Analog Scale and patient safety
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCA Cellular Therapy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel P Lasala, M.D., Principal investigator, TCA Cellular Therapy, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721006
- Sponsor's protocol ID
- 2008-01-II
- Acronym
- MESENDO
- Status last verified
- Sep 2010
- First submitted
- 21 Jul 2008
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lasala GP, Silva JA, Minguell JJ. Therapeutic angiogenesis in patients with severe limb ischemia by transplantation of a combination stem cell product. J Thorac Cardiovasc Surg. 2012 Aug;144(2):377-82. doi: 10.1016/j.jtcvs.2011.08.053. Epub 2011 Nov 12.
PubMed 22079876
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Safety/Efficacy Study of A Combination Stem Cell Therapy That Develops Mature Stable Vessel Formation in Ischemic Limbs
- ClinicalTrials.gov ID
- NCT00721006
- Acronym / sponsor ID
- MESENDO / 2008-01-II
- Conditions
- Critical Limb Ischemia, Severe Leg Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease
- Keywords
- peripheral artery disease, peripheral vascular disease, PAD, PVD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- TCA Cellular TherapyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Jul 2008 (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.
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.
Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.
LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.
In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.
Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.
Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MESENDO | Experimental | Biological: MESENDOAll subjects will receive active treatment in a blinded fashion in the left or right lower limb. The opposite lower limb will receive placebo. |
| placebo | Placebo comparator | Biological: PlaceboAll subjects will receive placebo injections in a blinded fashion in the left or right lower limb. The opposite lower limb will receive active stem cell infusion |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females older than 18 years of age.
- Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart.
- Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers.
- Claudication
- Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia.
Key exclusion criteria (12 listed)
- Inability to provide informed consent.
- Previous angiogenic therapy.
- Known sensitivity to gentamycin and/or amphotericin B.
- Use or expected use of antineoplastic drugs.
- Any illness, which might affect the patient's survival after enrollment in the protocol.
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 |
|---|---|---|
| MESENDO40 subcutaneous injections of biological product | Biological | MESENDO |
| Placebo40 subcutaneous injections of placebo | Biological | placebo |
Primary outcome
Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia.
Time frame: 4 months
1 secondary outcome
Changes in resting leg pain identified by a Visual Analog Scale and patient safety
Time frame: 4 months
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 9 May 2014.
- Derived from this study: PubMed 22079876Lasala GP, Silva JA, Minguell JJ. Therapeutic angiogenesis in patients with severe limb ischemia by transplantation of a combination stem cell product. J Thorac Cardiovasc Surg. 2012 Aug;144(2):377-82. doi: 10.1016/j.jtcvs.2011.08.053. Epub 2011 Nov 12.
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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.
Gabriel P Lasala, M.D. principal investigator
TCA Cellular Therapy, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MESENDO in people with Critical Limb Ischemia and Severe Leg Ischemia, run by TCA Cellular Therapy at 1 site in United States.
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 12 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 9 May 2014. 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 United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia. (time frame: 4 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 NCT00721006, which also lists 1 linked publication.
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 9 May 2014.