Bone marrow transplantation for osteonecrosis

Phase 1

• Conditions: Idiopathic Osteonecrosis of Femoral Head

• Registration Number: JPRN-jRCTc032200027
• Lead Sponsor: Yasuhiro Homma

Brief Summary

Safety of autologous concentrated bonemarrow transplantation using a point of care device for idiopathic osteonecrosis of the femoral head was validated.The study was completed without problems,with no serious adverse events.The appropriateness of proceeding to next study to test an efficacy of this procedure was demonstrated.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-07
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1) Idiopathic osteonecrosis of femoral head; Stage 1,2, and 3A
2) Age more than 20 years old

Exclusion Criteria

1) Patients with abnormal platelet counts in peripheral blood
2) Patient who smoke s a lot (Brinkman index > 600)
3) Treatment with anticoagulants (except for Bi aspirine)
4) Uncontrolled diabetes mellitus:HbA1c not lower than 9.0% according to latest laboratory data obtained within 14 days before registration
5) Patients with malignancy
6) Patients less than 6 months after onset of cardiac infarction or cerebral infarction
7) Predictive survival period is les s than 1 year
8) Active infectious disease (HBV, HCV, HIV, syphilis)
9) Dialysis patients
10) Less than 20 years old
11) Patiens with dementia or coma
12) Previous surgical history for proximal femur
13) Anesthesist has determined that it is not suitable for general anesthesia
14) Doctor has determined that it is not suitable for this clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
- Pain<br>- Hip Function<br>- Changement of staging<br>- Necrotic volume