Use of Adipose Tissue Derived Mesenchymal Stem Cells for Knee Osteoarthrosis

NCT ID: NCT02966951

Last Updated: 2021-04-28

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

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-17

Study Completion Date

2021-12-31

Brief Summary

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Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed with Knee osteoarthrosis

Detailed Description

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Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with Adipose Tissue derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.

Conditions

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Knee Osteoarthrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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adipose tissue mesenchymal stem cell

Intra-articular adipose tissue derived mesenchymal stem cell injection will be given for each patient in 2 doses, 50 million of ATMSC in each dose

Group Type EXPERIMENTAL

Adipose tissue derived mesenchymal stem cell

Intervention Type BIOLOGICAL

Intra-articular adipose tissue derived mesenchymal stem cell injection.

Interventions

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Adipose tissue derived mesenchymal stem cell

Intra-articular adipose tissue derived mesenchymal stem cell injection.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Severe KOA stage III or IV by Laurance \& Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.

Willing to participate by signing the informed consent

Exclusion Criteria

* Sublaxation beyond 20 degrees of the bones of the knee joint
* Oral anticoagulants or heparin therapy
* Heart failure or arrhythmia
* Body Mass Index \> 35
* Uncontrolled Diabetes Mellitus.
* Evidence of Infectious Diseases.
* Active infection
* Malignancy
* Pregnancy
* Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.
* Unreliable patients
* Non-resident in Jordan
Minimum Eligible Age

42 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanan Jafar

OTHER

Sponsor Role lead

Responsible Party

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Hanan Jafar

Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Abdallah Awidi, MD

Role: STUDY_DIRECTOR

Cell Therapy Center

Locations

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Cell Therapy Center

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Hanan Jafar, PhD

Role: CONTACT

00962798871087

Facility Contacts

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Abdalla Awidi, MD

Role: primary

0096265355000

Other Identifiers

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ATKneeUJCTC

Identifier Type: -

Identifier Source: org_study_id

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