Clinical trial NCT03103295: 3D Tissue Engineered Bone Equivalent for Treatment of Traumatic Bone Defects
Official title: Safety and Efficacy Study of Traumatic Bone Defects Treatment With Use of 3D Tissue Engineered Equivalent.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Bone Defects
Keywords: tissue engineering,
regeneration,
repair,
traumatic bone defects,
regenerative therapy
Lead sponsor: A.A. Partners, LLC
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates safety and efficacy of traumatic bone defects treatment with use of 3D tissue engineered bone equivalent (3D-TEBE).

The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient treatment for patients with traumatic long bone defects of critical size.

Detailed description: This new method of critical sized long bone defects treatment is under clinical development. Treatment of critical sized bone defects is an actual clinical challenge. The "gold standard" in this case is autologous bone grafting. The method disadvantage is associated with limited donor bone resources. Based on our preliminary clinical trial positive results on use of autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs) in traumatology, our aim was to develop 3D tissue-engineered bone equivalent transplantation technology for restoration of critical sized bone defects. The proposed 3D-TEBE transplantation for bone defects of critical size treatment expecting to restore the bone integrity, form new bone tissue in a site of bone defect, and reduce the rehabilitation period of a patient.

The data obtained from this study will have practical implications for the treatment of reparative osteogenesis alterations and will be based on the principles of evidence-based medicine

Eligibility criteria: Inclusion Criteria:

* Age 18 to 60 years
* Patients with long bone defects of critical size of the traumatic genesis;
* Lack of consolidation of bone fragments for at least 9 months;
* At least two attempts to achieve bone consolidation using traditional methods of treatment;
* A negative pregnancy test at women of childbearing age;
* Confirmation of participation in the study by signing The Written Informed Consent, personally or through a responsible caretaker;

Exclusion Criteria:

* The infection in the area of bone defect;
* History of prior cancer;
* Diabetes;
* Severe chronic liver diseases or kidneys disease in history
* Pregnancy;
* The presence of vascular, endocrine and somatic pathology which has a direct impact on the osteoreparation;
* Any other physical diseases in decompensation or subcompensation, or those that are rated as severe or moderate;
* Therapeutic issues or psychiatric disorders of a patient which would make the subject unsuitable to participate in this study or to complete it;
* Participation in another clinical trial.

Primary outcomes:
measure: Radiographic and MRI assessment in progression
timeFrame: 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting
Secondary outcomes:
measure: Reduction of pain using VAS
timeFrame: 6 months
measure: Cost analysis based on length of hospital stay
timeFrame: 6 months
Other outcomes:
Locations:
city: Kiev
country: Ukraine
facility: LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya®)
Study officials:
affiliation: LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya® ),
name: Volodymyr M. Oksymets, MD,PhD,DSci
role: PRINCIPAL_INVESTIGATOR
References: