A Phase I/ II Clinical Trial: Autologous CD34+ Cell Transplantation for Bone and Vascular Healing in Patients with Non-Union Fracture - Cellular Therapy for Patients with Non-Union Fracture

Ryosuke Kuroda, M.D., Ph.D.0 sites17 target enrollmentJanuary 8, 2010

Conditionson-Union Fracture

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: on-Union Fracture
Sponsor: Ryosuke Kuroda, M.D., Ph.D.
Enrollment: 17
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 8, 2010

End Date

July 1, 2012

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Ryosuke Kuroda, M.D., Ph.D.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\) Patients (Pts) with congenital femoral or tibial fracture 2\) Pts with multiple pseudoarthrosis 3\) Pts with radiation therapy, chemotherapy, steroid therapy or immunosuppressant 4\) Pts with limb paralysis due to cerebral infarction or spinal cord injury 5\) Pts with a history of severe allergic reactions or side effects to G\-CSF, collagen products or apheresis 6\) Pts with malignant tumor or with a history of malignant tumor in last 5 years 7\) Pts with diabetic proliferating retinopathy 8\) Pts with unstable angina 9\) Less than 6 months since last episode of myocardial/cerebral infarction 10\) Pts with leukemia, myeloproliferative disease, or myelodysplastic syndromes 11\) Pts with allergic reaction to atelocollagen 12\) Pts or their family currently suffering from or having a history of autoimmune disease 13\) Pts with end stage renal disease on maintenance hemodialysis 14\) Pts with cirrhosis of the liver 15\) Pts currently suffering from or having a history of interstitial pneumonitis 16\) Pts with cerebral aneurysm indicative for surgical/endovascular treatment by neurosurgeon 17\) Leukocytes less than 4,000/uL or exceeding 10,000/uL 18\) Platelets less than 100,000/uL 19\) Hemoglobin less than 8g/uL 20\) AST exceeding 100 IU/uL or ALT exceeding 100 IU/uL 21\) Pts with splenomegaly 22\) Pts with severe ulcer/ gangrene in the legs with pseudoarthrosis 23\) Pts with an operative treatment for the pseudoarthrosis performed in the last 9 months 24\) Pts having a plan of another operative treatment in the period of current clinical research 25\) Pts infected with HBV, HCV, HIV or HTLV 26\) Pts with infectious diseases accompanied by fever over 38 C 27\) Pts with uncontrollable mental diseases 28\) Pts participating in other clinical trials 29\) Pregnant or nursing patients, those who may be pregnant or plan on becoming pregnant before the end of the study period 30\) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study