Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment

Royan Institute

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Bone Fracture

Treatments: Other: Percutaneous injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02448849

Royan-Bone-013

Details and patient eligibility

About

Nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients.

Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.

Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.

The Spss(v16) software will be used for data analysis.

Full description

Long bone nonunion is known as a therapeutic challenge for both the orthopedic surgeons and the society. Current treatment of this disorder is autologous bone graft. This treatment has potential minor and major complications and is considered as a risky treatment. So researches are focused on new treatment approaches for this disease.

Cell therapy is one of these new approaches especially based on mesenchymal stromal cells.

The investigators will evaluate safety and efficacy of percutaneous implantation of autologous BM-MSC (bone marrow -derived mesenchymal stromal cell) in combination with PL (platelet lysate product) in 30 tibia nonunion patients. The other 30 patients will receive placebo. These patients will be followed up and data will be analyzed with spss(v16).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-united fracture of tibial midshaft at X-ray.
• Non-united gap less than 1cm.
• Fracture has fixed by closed intramedullary rod.
• Hypotrophic type.
• At least 6 months after initial surgery.
• Patient informed consent.

Exclusion criteria

• Infected nonunion
• Multiple major fracture
• Non treated major fracture
• malignancy
• Pregnancy or lactating
• Uncontrolled chronic diseases, such as: diabetes mellitus, hypertension, renal diseases, liver diseases, thyroid diseases, heart diseases, blood diseases, etc.
• Steroid usage.
• Positive test for HIV and/or HBS and/or HBC and/or HTLV (1,2)
• Fracture site more than 1 cm.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

MSC recipients

Experimental group

Description:

The patients with nonunion fracture who underwent percutaneous implantation of bone marrow derived mesenchymal stem cells in combination with platelet lysate product.

Placebo

Placebo Comparator group

Description:

The patients with nonunion fracture who underwent percutaneous injection of placebo.

Treatment:

Other: Percutaneous injection

Other: Percutaneous injection