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

• Sponsor: zaid husein ali (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05193877
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.7
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Treatment Complication	Procedure: autologous bone marrow aspirate concentrate by centrifugation	N/A

Detailed Description

1. To evaluate the efficacy of bone marrow aspirate concentrate (BMAC) therapy on pain, function and disease modification in knee osteoarthritis.

2. To determine the potential of BMAC therapy to achieve disease modification, as detected through radiological examination using magnetic resonance imaging (MRI) techniques.

3. 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double blinddouble blind
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis: a Randomized Controlled Trial, Ibn-Sina Hospital, Baghdad 2022
• Actual Study Start Date: Feb 8, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: treatment with autologous bone marrow aspirate concentrate 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; 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.
Sham Comparator: control control group given analgesics only	Procedure: autologous bone marrow aspirate concentrate by centrifugation; 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.

Outcome Measures

Primary Outcome Measures

1. clinical [6 months]

   improvement in pain scale WOMAC

Secondary Outcome Measures

1. radiological proof [6 months-1 year]

   MRI of the knee joint to monitor effect

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ibn Sina	Baghdad		Iraq	964

Sponsors and Collaborators

• zaid husein ali

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: zaid husein ali, global stem cell group, Global Stem Cell Center, Baghdad
• ClinicalTrials.gov Identifier: NCT05193877
• Other Study ID Numbers: Ibn-sina protocol
• First Posted: Jan 18, 2022
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Mar 21, 2022