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Bone Marrow Cells With Core Decompression for AVN Treatment

Primary Purpose

Avascular Necrosis of the Femoral Head

Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
core decompression with local bone marrow mononuclear cells injection
Sponsored by
Global Stem Cell Center, Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Avascular Necrosis of the Femoral Head focused on measuring avascular necrosis of the femoral head, core decompression, bone marrow cells, local anesthesia

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Avascular hip necrosis irrespective Of stage. age from 25-55 years. - Exclusion Criteria: history of bleeding tendency. history of malignant disease. critically ill patient. -

Sites / Locations

  • Ministry of HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

bone marrow injection

Arm Description

injection of autologous concentrated bone marrow cells under ultrasound and fluoroscopy guide after core decompression

Outcomes

Primary Outcome Measures

clinical improvement
change in Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad.

Secondary Outcome Measures

disease progression
percentage of patients who have clinical progress using Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad or radiological proof of disease progression by Mitchell classification which is used to stage osteonecrosis of the femoral head and is based on MRI signal characteristics within the center of the lesion and classified into four stages with stage A representing early disease and stage D representing late disease.

Full Information

First Posted
July 18, 2023
Last Updated
August 11, 2023
Sponsor
Global Stem Cell Center, Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05982054
Brief Title
Bone Marrow Cells With Core Decompression for AVN Treatment
Official Title
Percutaneous Autologous Bone Marrow Cells With Core Decompression for Treating Avascular Hip Necrosis Under Local Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
January 24, 2024 (Anticipated)
Study Completion Date
January 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Global Stem Cell Center, Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. this is a single armed study to be done from July 2023 till January 2024, the total number of patients anticipated is 10, total joints treated around 20, The procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.
Detailed Description
Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. Early stage AVN can be managed by various techniques, the results have been disappointing, total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. This procedure is usually a high risk procedure under general anesthesia ,with The newer treatment modalities include using high stem cell concentration in the vicinity of the necrosed tissue with core decompression to prevent disease progression. this study is a single armed study to be done from July 2023 to January 2024, the total number of patients is 10, Etiology include corticosteroids use, systemic lupus erythematosus mostly related to steroid use in covid 19 epidemic,. The age of the patients range from 25-55 years. The procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis of the Femoral Head
Keywords
avascular necrosis of the femoral head, core decompression, bone marrow cells, local anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bone marrow injection
Arm Type
Other
Arm Description
injection of autologous concentrated bone marrow cells under ultrasound and fluoroscopy guide after core decompression
Intervention Type
Procedure
Intervention Name(s)
core decompression with local bone marrow mononuclear cells injection
Intervention Description
under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide
Primary Outcome Measure Information:
Title
clinical improvement
Description
change in Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
disease progression
Description
percentage of patients who have clinical progress using Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad or radiological proof of disease progression by Mitchell classification which is used to stage osteonecrosis of the femoral head and is based on MRI signal characteristics within the center of the lesion and classified into four stages with stage A representing early disease and stage D representing late disease.
Time Frame
around 6 months from starting recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Avascular hip necrosis irrespective Of stage. age from 25-55 years. - Exclusion Criteria: history of bleeding tendency. history of malignant disease. critically ill patient. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
abdulmajeed A hammadi, MD
Phone
+9647902268105
Email
majeed51578@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
khalil J kareem, MD
Phone
+9647803977072
Email
khaliljumakareem69@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abdulmajeed a hammadi, MD
Organizational Affiliation
clinical stem cell studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health
City
Baghdad
ZIP/Postal Code
964
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
thamer M alrubaie, MD
Phone
+9647700009294
Email
alzaitounhospital@gmail.com

12. IPD Sharing Statement

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Bone Marrow Cells With Core Decompression for AVN Treatment

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