Mesenchymal Stem Cells in Knee Cartilage Injuries

NCT ID: NCT02118519

Last Updated: 2016-02-24

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Fourteen patients from both genders, age range 40-68, will be enrolled according to strict inclusion and exclusion criteria, divided into two equal groups based upon receiving autologous MSCs alone, or MSCs supported by platelet lysate through percutaneous injection.

The patients are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.

The investigators hypothesize that the two groups will give satisfactory clinical outcomes, but the investigators are looking forward to assessing the best product that will activate chondrogenesis and heal cartilaginous injury.

Conditions

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Articular Cartilage Disorder of Knee Osteoarthritis, Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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mesenchymal stem cells

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

Group Type ACTIVE_COMPARATOR

Autologous Mesenchymal Stem Cells

Intervention Type BIOLOGICAL

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 lysate

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

Group Type ACTIVE_COMPARATOR

Autologous Mesenchymal Stem Cells

Intervention Type BIOLOGICAL

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

Interventions

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Autologous Mesenchymal Stem Cells

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Fatima Jamali

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdallah Awidi, MD

Role: STUDY_DIRECTOR

Cell Therapy Center

Mahasen S Najjar, MD

Role: PRINCIPAL_INVESTIGATOR

Jordan University Hospital

Hiba Khalil, PhD

Role: PRINCIPAL_INVESTIGATOR

Al-Neelain University

Locations

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Cell Therapy Center, Jordan University Hospital

Amman, , Jordan

Site Status

Countries

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Jordan

References

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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.

Reference Type DERIVED
PMID: 29233163 (View on PubMed)

Other Identifiers

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KneeUJCTC

Identifier Type: -

Identifier Source: org_study_id

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