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Bone Graft
Title: Reamer Irrigation Aspirator (RIA) Effluent Evaluation.
Purpose: To see if growth factors can be captured (specifically BMP-2) from RIA effluent using a Synthes proprietary technology.
Eligibility: See contact information below.
Principal Investigator: Conway, Janet D.
Phase: I
For more information, contact: Stacy Specht
Telephone Number: 410-601-9467
Email: [email protected]
Title: A Phase I Study to Determine the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in
Patients with Degenerative Joint Disease Prior to Total Knee Arthroplasty. (TGC-03-01)
Purpose: To investigate the safety and bioavailability of TissueGene-C administered intra-articularly (IA) to patients with Degenerative
Joint Disease, once over a four (4) week period prior to their scheduled total knee arthroplasty.
Eligibility: A total of twelve (12) patients (men and women), at Sinai Hospital of Baltimore, with Degenerative Joint Disease who are
scheduled for knee surgery between the ages of 18 and 80 will take part in this randomized, single-blind study.
Principal Investigator: Mont, Michael A.
Phase: I
For more information, contact: MaryLou Mullen
Telephone Number: 410-601-8609
Email: [email protected]
07-13-2010
Epithelial Ovarian & Primary Peritoneal Carcinomas
Title: A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab for the
Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior
Therapy With a Platinum/Taxane-Based Chemotherapy. (Biogen 206OC202)
Purpose: To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or
primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
Eligibility: See contact information below.
Principal Investigator: Abbas, Fouad M.
Phase: I/II
For more information, contact: Judy Bosley
Telephone Number: 410-601-9083
Email: [email protected]
07-13-2010
Osteonecrosis
Title: Multi-center Clinical Trial of the Application of Tissue Repair Cell (TRC) Therapy of Osteonecrosis of the Femoral Head.
(Protocol ABI-55-0705-1 Rev 01)
Purpose: To evaluate the use of tissue repair cells to prevent the progression of osteonecrosis of the hip. Tissue repair cells are the
patient's own bone marrow cells, removed from the patient's pelvic bone, grown and processed in a nutrient-rich solution, and
mixed with bone proteins and blood proteins.
Eligibility Men and women between the ages of 18 and 75 may participate in this study. Only patients who have damage to greater than
15% of the bone without collapse of the bone will be considered for this study. Patients will be carefully screened prior to
enrollment to ensure that they are healthy enough for this procedure; have no allergies that could interfere with the procedure,
have normal bone marrow, kidney, and liver function; and have no infection in affected bones. For inclusion in the study, females
cannot be pregnant or lactating, and all patients should be using appropriate contraception for 24 months after the procedure.
Patients should also not be using biphosphonate medications for six months prior to the procedure, because these medications can
prevent the breakdown of dead bone cells.
Principal Investigator: Mont, Michael A.
Phase: III
For more information, contact: MaryLou Mullen
Telephone Number: 410-601-8609
Email: [email protected]
07-13-2010
Total Hip Arthroplasty
Title: Deep Vein Thrombosis Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy versus Low Molecular
Weight Heparin. (R-QAP-04-01-01-001)
Purpose: To evaluate the safety and effectiveness of ActiveCare Continuous Enhanced Circulation Therapy (CECT) device with or
without baby aspirin (81 mg aspirin daily) for lowering the potential risk of Deep Vein Thrombosis (blood clots) during and after
Total Hip Arthroplasty (THA) in comparison with Low Molecular Weight Heparin (LMWH).
Eligibility A total of 480 patients (men and women) in multiple centers with Degenerative Joint Disease who are scheduled for elective
Total Hip Arthroplasty (THA) and are 18 years of age or older are eligible to take part in this study. Sinai Hospital anticipates
enrolling approximately 100 patients.
Principal Investigator: Mont, Michael A.
Phase: IV
For more information, contact: MaryLou Mullen
Telephone Number: 410-601-8609
Email: [email protected]
07-13-2010