NCT02966951

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

4.6 years

First QC Date

November 15, 2016

Last Update Submit

April 27, 2021

Conditions

Knee Osteoarthrosis

Keywords

osteoarthrosiskneeadipose tissuestem cellscell therapy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the safety and tolerability of the intra articular injection

    patients will be monitored for any adverse events resulting from the intraarticular injection of ATMSC

    Time Frame: 6 months

Secondary Outcomes (1)

  • Assessment of the efficacy of intra-articular injection of ATMSC

    12 months

Study Arms (1)

adipose tissue mesenchymal stem cell

EXPERIMENTAL

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

Biological: Adipose tissue derived mesenchymal stem cell

Interventions

Adipose tissue derived mesenchymal stem cellBIOLOGICAL

Intra-articular adipose tissue derived mesenchymal stem cell injection.

adipose tissue mesenchymal stem cell

Eligibility Criteria

Age42 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Therapy Center

Amman, 11942, Jordan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Abdallah Awidi, MD

    Cell Therapy Center

    STUDY DIRECTOR

Central Study Contacts

Hanan Jafar, PhD

CONTACT

00962798871087hanan.jafar@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 17, 2016

Study Start

January 17, 2017

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

JO(1)