Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis:Baghdad 2022

Study Overview
=================
Brief Summary
-----------------
We present a randomized controlled trial (RCT) to assess the efﬁcacy of autologous bone marrow aspirate concentrate BMAC of 1.8x 10 9 median cellular content in the treatment of early symptomatic knee OA. We use 2 injections 2 months apart (8).

Detailed Description
-----------------
To evaluate the efficacy of bone marrow aspirate concentrate (BMAC) therapy on pain, function and disease modification in knee osteoarthritis. To determine the potential of BMAC therapy to achieve disease modification, as detected through radiological examination using magnetic resonance imaging (MRI) techniques. Methodology: A randomized controlled trial will be held in Ibn-Sina training hospital in Baghdad. All participants will complete written informed consent. The study will be a single centered trial. The trial design will consist of 60 participant randomly and equally allocated to control and treatment group by simple random sampling. Participants will not be blinded to their treatment allocation. Control group will receive conventional treatment only. Intervention group will receive (2 injections) intra-articular injections of (4cc) per joint at (8 weeks' interval). Intervention: 50 cc bone marrow aspirates concentrate after centrifugation with final volume up to 7 cc. Assess total nucleated count and viability. Bone marrow aspirate concentrate is chosen as a source of mesenchymal stem cells, because of safe and easy procedure. Bone marrow aspiration is done under local or general anesthesia, depending on the individual case. Around 50 cc of bone marrow is aspirated from the posterior iliac crest after proper sterilization using bone marrow aspiration needle (size according to the patient) and collected in heparinized syringes. Mononuclear cells (MNCs) are obtained by centrifugation. The isolated MNCs are checked for viability manually and confirmed on automated cell count machine. The separated MNCs is administered intra-articularly immediately after centrifugation. Place: Bone marrow aspiration and centrifugation procedure is done in clean area, in operation room HEPA filtered with all instruments included. Cell count viability and flow cytometry can be sent to nearby lab.CD markers (90, 44,29,105,34). Instruments: Bone marrow aspiration kit, centrifuge, automated cell counter. Sample size and sampling technique: The conventional treatment is usually classic treatment . Statistical analysis: Raw data will be summarized, and presented in appropriate table. The statistical analysis will be carried out using SPSS (statistical package for social science) software version 25

Official Title
-----------------
Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis: a Randomized Controlled Trial, Ibn-Sina Hospital, Baghdad 2022

Conditions
-----------------
Treatment Complication

Intervention / Treatment
-----------------
* Procedure: autologous bone marrow aspirate concentrate by centrifugation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiological diagnosis of Osteoarthritis according to Kellgren and Lawrence Criteria stage II-III. Radiological grading of osteoarthritis of the knee determined by qualified radiologist using MOAKS scoring system. Primary osteoarthritis not responsive to conventional treatment and physiotherapy. A minimum pain score of 5 on an 11-point numerical scale. Age >55 years Exclusion Criteria: Pregnancy and breast feeding. Knee symptom due to other condition like tumor or referred pain from lumbar spine. MRI confirmed displaced meniscal tear MRI confirmed Grade IV chondral loss. Previous knee surgery within the last 12 months. Previous intra-articular injectable therapies within the last 6 months History of severe systemic illness. Active neoplasm under treatment in the last 12 months- Health conditions including known allergy to local Bleeding tendency.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment with autologous bone marrow aspirate concentrate<br>autologous bone marrow aspirate is taken under local anesthesia to be centrifuged and the concentrate given intra articularly in knee joint | Procedure: autologous bone marrow aspirate concentrate by centrifugation<br>* 50 cc bone marrow aspirates concentrate after centrifugation with final volume up to 7 cc. Assess total nucleated count and viability. Bone marrow aspirate concentrate is chosen as a source of mesenchymal stem cells, because of safe and easy procedure. Bone marrow aspiration is done under local or general anesthesia, depending on the individual case. Around 50 cc of bone marrow is aspirated from the posterior iliac crest after proper sterilization using bone marrow aspiration needle (size according to the patient) and collected in heparinized syringes. Mononuclear cells (MNCs) are obtained by centrifugation. The isolated MNCs are checked for viability manually and confirmed on automated cell count machine. The separated MNCs is administered intra-articularly immediately after centrifugation.<br>|
| Sham Comparator: control<br>control group given analgesics only | Procedure: autologous bone marrow aspirate concentrate by centrifugation<br>* 50 cc bone marrow aspirates concentrate after centrifugation with final volume up to 7 cc. Assess total nucleated count and viability. Bone marrow aspirate concentrate is chosen as a source of mesenchymal stem cells, because of safe and easy procedure. Bone marrow aspiration is done under local or general anesthesia, depending on the individual case. Around 50 cc of bone marrow is aspirated from the posterior iliac crest after proper sterilization using bone marrow aspiration needle (size according to the patient) and collected in heparinized syringes. Mononuclear cells (MNCs) are obtained by centrifugation. The isolated MNCs are checked for viability manually and confirmed on automated cell count machine. The separated MNCs is administered intra-articularly immediately after centrifugation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical | improvement in pain scale WOMAC | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological proof | MRI of the knee joint to monitor effect | 6 months-1 year |