The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone

The purpose of this study is to compare use of a tissue-engineered bone to use of a standard allograft bone to treat bone defect in patients. The hypothesis is that use of the tissue-engineered bone is effective and safe to treat the bone defect in patients.

Study Overview

• Status: Unknown
• Conditions: Bone Defect; Bone Nonunion
• Intervention / Treatment: Device: allograft bone; Device: tissue-engineered bone

Detailed Description

Patients with the bone defect without infection and sever system diseases will be recruited.

The material selected as the scaffold for this study will be a porous β-tricalcium phosphate scaffold (β-TCP) scaffold and scaffold is custom-made according to the size and shape of bone defect after three-dimensional CT scan. Human BMSCs will be obtained and cultured before operation and 3.4×106 cells in 10ml serum-free medium will be seeded onto scaffold to construct the tissue engineered bone graft and co-cultured for two weeks.

The implant operation will be carried out under the general anesthesia. The tissue engineered bone graft will be implanted into the bone defect area. The bone defect area will be covered with surrounding soft tissue and muscle to close the wound. Anti-inflammatory, repercussive and analgesic drugs will be used for 1 week.

Patient will be hospitalized for 1 to 2 weeks after surgery. Blood routine examination, erythrocyte sedimentation rate, immunoglobulin, autoantibodies and clinical examination will be carried out for signs of pain, swelling, immune rejection and infection. Patient will be evaluated at 3 days，3, 6, 12, 18 and 22 months after operation by radiography; Three-dimensional CT scan will be also performed at regular intervals. The function of the body will be evaluated at regular intervals.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: long bi, MD,PHD; Phone Number: +86 02984773524; Email: bilong@fmmu.edu.cn

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Department of Orthopedics, Xijing Hospital, The Fourth Military Medical University
      • Contact: long bi, MD,PHD; Phone Number: +86 02984773524; Email: bilong@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• the patients with bone defect and bone nonunion caused by tumor or trauma
• the length of bone defect in long diaphysis is more than 4cm or more than half of the shaft diameter
• the size of bone defect is more than 5cmx5cm
• the patients are unable to use autologous bone graft or other treatments
• the patients request to use the treatment of tissue-engineered bone
• Supportive family with willingness to participate in completing questionnaires

Exclusion Criteria:

• Patients with serious diseases such as hemorrhagic disorders, infection, tumor, contagion and so on.
• Patients who are pregnant
• Patients with serious abnormal cardiopulmonary function
• Patients disagree to use the tissue-engineered bone
• Patients are older than 60 years
• Patients who are regarded to be unqualified by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: allograft bone; traditional allograft bone	Device: allograft bone; Use of the allograft bone to treat the bone defect in patients
Experimental: tissue-engineered bone	Device: tissue-engineered bone; Use of the tissue-engineered bone to treat the bone defect in patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The scores of bone healing	The scores of bone healing are divided into three kinds: nonhealing: 0; delayed healing: 1; normal healing: 2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
the adverse event incidence using tissue-engineered bone and allograft bone	the adverse event incidence of tissue-engineered bone is compared with the adverse event incidence of allograft bone to verify the safety of tissue-engineered bone.	within 24 weeks after surgical treatment of bone dect

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The scores of blood routine test	The scores of blood routine test after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of erythrocyte sedimentation rate(ESR)	The scores of erythrocyte sedimentation rate (ESR) after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of C-reactive protein	The scores of C-reaction protein after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of the ratio of complement C3 to complement C4	The scores of ratio of complement C3 to C4 after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of immunoglobulin assay	The scores of immunoglobulin assay (IgG, IgA and IgM) after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of duration of hospital stay	The scores of duration of hospital stay are divided into four kinds: longer than one months: 0; longer than two weeks:1; longer than one week:2; less than one week:3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
the scores of time of weight loading after operation	The scores of time of weight loading after operation are divided into three kinds: longer than six months: 0; longer than three months:1; less than three months:2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of tumorigenesis	The scores of tumorigenesis after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of treatment course	The scores of treatment course are divided into three kinds: long：0；general ：1；short：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of number of operations	The scores of number of operations are divided into four kinds: above three times：0； three times：1；two times：2；one time：3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of pain	The scores of pain after operation are divided into four kinds: severe:0;moderate:1;slight:2; none:3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect
The scores of wound healing of soft tissue	The scores of wound healing are divided into four kinds: infection: 0; no healing: 1; delayed healing: 2; normal healing: 3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.	within 48 weeks after surgical treatment of bone dect

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: bilong11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED