NCT02118519

Brief Summary

Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

January 24, 2014

Last Update Submit

February 23, 2016

Conditions

Articular Cartilage Disorder of KneeOsteoarthritis, Knee

Keywords

Bone marrow derived Mesenchymal Stem CellsKnee articular cartilage injuryChondrogenesisorthopedics

Outcome Measures

Primary Outcomes (1)

  • Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.

    12 months

Secondary Outcomes (1)

  • Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.

    12 months

Study Arms (2)

mesenchymal stem cells

ACTIVE COMPARATOR

Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury

Biological: Autologous Mesenchymal Stem Cells

mesenchymal cells&platelet lysate

ACTIVE COMPARATOR

Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury

Biological: Autologous Mesenchymal Stem Cells

Interventions

Autologous Mesenchymal Stem CellsBIOLOGICAL

Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate

mesenchymal cells&platelet lysatemesenchymal stem cells

Eligibility Criteria

Age40 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MRI must show moderate/severe articular injury
  • Serum collagen II must be above the normal value.
  • Lesion site: Femoral and Tibial condyles or patella
  • Admission of steroid , NSAID, pain killers must be stopped before 1 month

You may not qualify if:

  • Lesion size
  • PT and PTT not within normal value
  • Complete blood count ( Hb, PCV, and RBC) not within the normal value
  • HIV and Hepatitis Antigens (B and C) detection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Therapy Center, Jordan University Hospital

Amman, 11942, Jordan

Location

Related Publications (1)

  • Al-Najar M, Khalil H, Al-Ajlouni J, Al-Antary E, Hamdan M, Rahmeh R, Alhattab D, Samara O, Yasin M, Abdullah AA, Al-Jabbari E, Hmaid D, Jafar H, Awidi A. Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study. J Orthop Surg Res. 2017 Dec 12;12(1):190. doi: 10.1186/s13018-017-0689-6.

    PMID: 29233163DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Abdallah Awidi, MD

    Cell Therapy Center

    STUDY DIRECTOR

  • Mahasen S Najjar, MD

    Jordan University Hospital

    PRINCIPAL INVESTIGATOR

  • Hiba Khalil, PhD

    Al-Neelain University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 24, 2014

First Posted

April 21, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

JO(1)