Basic research on long-term storage and clinical application of autologous bone

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500109372

Enrollment

Unknown

Registered

2025-09-17

Start date

2025-09-30

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone defect

Interventions

Case group:none

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Basic conditions for patients: 1. Age 18-75 years old, gender is not limited 2. Undergo primary joint replacement and osteotomy, and autologous bone needs to be amputated 3. Signed informed consent form and voluntarily participated in the study Bone tissue conditions: 1. Autologous bone volume obtained intraoperatively >=2 cm³ (ensure sufficient experimental analysis) 2. No visible necrosis, cysts or pathological fractures 3. Intraoperative aseptic operation collection (incision meets the standard of class I surgery) Clinical Data Integrity: 1. Complete record of the patient's basic information (age, gender, BMI, primary disease) 2. Provide preoperative blood test results (normal infection indicators such as CRP, ESR, WBC)

Exclusion criteria

Exclusion criteria: Patient-related exclusions: 1. Concomitant active infection (e.g., osteomyelitis, sepsis) or immune system disease (e.g., rheumatoid arthritis, HIV) 2. Long-term use of immunosuppressants or antibiotics (within 3 months before surgery) 3. Metabolic bone disease (such as severe osteoporosis, Paget's disease) 4. Patients with malignant tumors (primary bone tumors or metastases invading bone tissue) Bone tissue-related exclusions: 1. Risk of intraoperative contamination (e.g., bowel/genitourinary surgery performed at the same time) 2. Pathological examination showed that the rate of bone tissue necrosis > 10% (HE staining evaluation) 3. Positive microbial culture (pathogenic bacteria found by rapid preoperative or intraoperative test) Data Missing Exclusions: 1. Missing key clinical information (e.g., not recording ex-vivo time, storage temperature deviation >±5°C)

Design outcomes

Primary

Measure	Time frame
Bone mass measurement;immunogenicity;	—

Countries

China

Contacts

Public ContactHao Shen

Department of Orthopedics, Shanghai Sixth People’s Hospital

shenhao7212@shsmu.edu.cn+86 189 3017 7367

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026