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The clinical research of security and validity for applying enriched bone marrow stem cells rapidly recombinating parous biomaterial to multi-segment lumber intervertebral fusion

The clinical research of security and validity for applying enriched bone marrow stem cells rapidly recombinating parous biomaterial to multi-segment lumber intervertebral fusion

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17010805
Enrollment
Unknown
Registered
2017-03-06
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

lumber spine degeneration disease and lumbar vertebral fracture

Interventions

treatment group:using enriched bone marrow stem cells recombinating parous biomaterial for implantation
controlled group:autologous bone transplantation

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged from 18 to 65 years, male and female; (2) Two or three segmental lumber spine disease requiring decompression surgery and intervertebral fusion; (3) No admission for other clinical study in recent three months; (4) No acute infection,mental disorder and calcification metabolic disorders; (5) Be willing to sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) pathological fracture caused by osteopathy such as benign or malignant tumor; (2) acute or severe infection or chronic infection in its active phase; (3) osteoporosis,lacking critical bone in fracture site or comminuted fracture; (4) metabolic disorders,immune dysfunction or drug abuse; (5) accompanied of cardiac,lung,liver,kidney,hemopoietic system or endocrine system disease; (6) be allergic to implants or various medicine; (7) pregnant woman or lactating women; (8) patients unwilling or cannot limit activities or follow medical advice; (9) too weak to evaluate the security and validity of implants.

Design outcomes

Primary

MeasureTime frame
fusion rate;

Secondary

MeasureTime frame
JOA score;intervertebral space height;enrichment rate of stem cells;

Countries

China

Contacts

Public ContactJie Zhao

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

prof_zhao@189.cn+86 15921963129

Outcome results

None listed

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