Clinical trial NCT02448849: Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment
Official title: Use of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Combination With Platelet Lysate Product for Human Long Bone Nonunion Treatment, A Phase 2-3 Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Bone Fracture
Keywords: Autologous
nonunion fracture
bone marrow
mesenchymal
stromal cell
platelet lysate product
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2015-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: clinical union
timeFrame: 3months
measure: Radiological healing
timeFrame: 1week
Secondary outcomes:
measure: Pain
timeFrame: 3months
measure: Quality of life
timeFrame: 3months
measure: Walking distance
timeFrame: 3months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Regenerative medicine department and cell therapy center of Royan Institute
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Department of orthopedic surgery, Tehran university of medical science, Tehran, Iran
name: Mohammad Razi, MD
role: STUDY_DIRECTOR
affiliation: Cell therapy center of Royan Institute
name: Mohsen Emadedin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Regenerative Medicine and cell therapy center, Royan Institute
name: Narges Labibzadeh, MD
role: PRINCIPAL_INVESTIGATOR
References: