Status:
COMPLETED
Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
Lead Sponsor:
TCA Cellular Therapy
Conditions:
Critical Limb Ischemia
Severe Leg Ischemia
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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 cont...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00721006
Start Date
June 1 2008
End Date
September 1 2010
Last Update
May 9 2014
Active Locations (1)
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1
TCA Cellular Therapy
Covington, Louisiana, United States, 70433