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

Primary Purpose

Bone Fracture

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Percutaneous injection
Percutaneous injection
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Fracture focused on measuring Autologous, nonunion fracture, bone marrow, mesenchymal, stromal cell, platelet lysate product

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Royan InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MSC recipients

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

clinical union
- Clinical union is defined as an asymptomatic patient who was able to fully bear weight on the injured leg
Radiological healing
- radiographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results

Secondary Outcome Measures

Pain
The pain relief as measured by Visual Analogue Scale (VAS) 3 months after cell injection
Quality of life
Evaluation the patients' quality of life with Visual Analogue Score (VAS) 3months after cell transplantation.
Walking distance
Walking distance changes as measured by walking on treadmill 3 months after cell injection.

Full Information

First Posted
May 5, 2015
Last Updated
October 29, 2015
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02448849
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fracture
Keywords
Autologous, nonunion fracture, bone marrow, mesenchymal, stromal cell, platelet lysate product

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MSC recipients
Arm Type
Experimental
Arm Description
The patients with nonunion fracture who underwent percutaneous implantation of bone marrow derived mesenchymal stem cells in combination with platelet lysate product.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients with nonunion fracture who underwent percutaneous injection of placebo.
Intervention Type
Biological
Intervention Name(s)
Percutaneous injection
Intervention Description
percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.
Intervention Type
Other
Intervention Name(s)
Percutaneous injection
Intervention Description
Percutaneous implantation of placebo in patients with nonunion fracture.
Primary Outcome Measure Information:
Title
clinical union
Description
- Clinical union is defined as an asymptomatic patient who was able to fully bear weight on the injured leg
Time Frame
3months
Title
Radiological healing
Description
- radiographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results
Time Frame
1week
Secondary Outcome Measure Information:
Title
Pain
Description
The pain relief as measured by Visual Analogue Scale (VAS) 3 months after cell injection
Time Frame
3months
Title
Quality of life
Description
Evaluation the patients' quality of life with Visual Analogue Score (VAS) 3months after cell transplantation.
Time Frame
3months
Title
Walking distance
Description
Walking distance changes as measured by walking on treadmill 3 months after cell injection.
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser Aghdami, MD, PhD
Phone
(+98)23562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Arab, MD
Phone
(+98)23562000
Ext
414
Email
Leara91@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Regenerative medicine department and cell therapy center of Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Razi, MD
Organizational Affiliation
Department of orthopedic surgery, Tehran university of medical science, Tehran, Iran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Emadedin, MD
Organizational Affiliation
Cell therapy center of Royan Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Narges Labibzadeh, MD
Organizational Affiliation
Department of Regenerative Medicine and cell therapy center, Royan Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Phone
(+98)23562000
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name & Degree
Leila Arab, MD
Phone
(+98)23562000
Ext
414
Email
Leara91@gmail.com

12. IPD Sharing Statement

Links:
URL
http://RoyanInstitute.org
Description
Related Info

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

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