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

NCT ID: NCT02448849

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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).

Conditions

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Bone Fracture

Keywords

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Autologous nonunion fracture bone marrow mesenchymal stromal cell platelet lysate product

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MSC recipients

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

Group Type EXPERIMENTAL

Percutaneous injection

Intervention Type BIOLOGICAL

percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.

Placebo

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

Group Type PLACEBO_COMPARATOR

Percutaneous injection

Intervention Type OTHER

Percutaneous implantation of placebo in patients with nonunion fracture.

Interventions

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Percutaneous injection

percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.

Intervention Type BIOLOGICAL

Percutaneous injection

Percutaneous implantation of placebo in patients with nonunion fracture.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of Regenerative medicine department and cell therapy center of Royan Institute

Mohammad Razi, MD

Role: STUDY_DIRECTOR

Department of orthopedic surgery, Tehran university of medical science, Tehran, Iran

Mohsen Emadedin, MD

Role: PRINCIPAL_INVESTIGATOR

Cell therapy center of Royan Institute

Narges Labibzadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine and cell therapy center, Royan Institute

Locations

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Royan Institute

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Nasser Aghdami, MD, PhD

Role: CONTACT

Phone: (+98)23562000

Email: [email protected]

Leila Arab, MD

Role: CONTACT

Phone: (+98)23562000

Email: [email protected]

Facility Contacts

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Nasser Aghdami, MD,PhD

Role: primary

Leila Arab, MD

Role: backup

Related Links

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http://RoyanInstitute.org

Related Info

Other Identifiers

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Royan-Bone-013

Identifier Type: -

Identifier Source: org_study_id