Bone Marrow Cells With Core Decompression for AVN Treatment

NCT ID: NCT05982054

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2024-07-28

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.

Conditions

Avascular Necrosis of the Femoral Head

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bone marrow injection

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

Group Type: OTHER

core decompression with local bone marrow mononuclear cells injection

Intervention Type: PROCEDURE

under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide

Interventions

core decompression with local bone marrow mononuclear cells injection

under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Avascular hip necrosis irrespective Of stage.

2. age from 25-55 years. -

Exclusion Criteria

1. history of bleeding tendency.

2. history of malignant disease.

3. critically ill patient. -

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Global Stem Cell Center, Baghdad

INDUSTRY

Sponsor Role: lead

Responsible Party

abdulmajeed hammadi

GSCCBaghdad

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

abdulmajeed a hammadi, MD

Role: PRINCIPAL_INVESTIGATOR

clinical stem cell studies

Locations

Ministry of Health

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

KM protocol

Identifier Type: -

Identifier Source: org_study_id