Status:
TERMINATED
Autologous/Allogeneic Progenitor Stem Cell Therapy for Congestive Heart Failure
Lead Sponsor:
Amit, Patel N, M.D.
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research study is being performed to find out more information about the safety and effectiveness of injecting bone marrow progenitor cells (BMPCs) from one's own hip bone into one's heart muscle...
Eligibility Criteria
Inclusion
- Age \>=18 years.
- Congestive heart failure with ejection fraction \<= 35.
- Candidates for ventricular device placement as a bridge to transplant.
- Serum bilirubin, SGOT and SGPT \<= 2.5 times the upper level of normal.
- Serum creatinine \< 2.0 times normal or no dialysis.
- New York Heart Association (NYHA) performance status \> 3.
- Negative pregnancy test (in women with childbearing potential).
Exclusion
- Pregnant or breastfeeding women.
- History of prior radiation exposure.
- History of bone marrow disorder.
- History of abnormal bleeding or clotting.
- History of liver cirrhosis.
- Inability to obtain 1 x 10\^6 CD 34+ cells after bone marrow processing.
- Acute myocardial infarction \< 6 days from acute event.
- Prior malignancy in the 5 years before treatment in this study (other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer).
- Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
- Eligible for destination ventricular assist device placement.
- Unable to have 250cc bone marrow harvested.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00128258
Start Date
May 1 2005
End Date
December 1 2016
Last Update
January 19 2018
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