Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee

Articular Cartilage Disorder of Knee Clinical Trial

Official title:

Multicenter, Randomized, Open-Label, Standard Treatment-Controlled Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells and Hyaluronic Acid Adjuvant Therapy Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee With an Optional Open-Label Extension for the Standard Treatment-Controlled Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101163
• Other study ID #: KLSMC-003
• Status: Completed
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: July 2022

Study information

• Verified date: March 2022
• Source: KLSMC Stem Cells, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).

Description:

This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Aged between 18 to 55 years at screening (20 to 57 years for the open-label extension)

• Present for evaluation and treatment of knee pain, knee swelling, or knee mechanical symptoms due to cartilage lesions

• Provide written informed consent

• International Cartilage Repair Society (ICRS) Grade 3 or 4 lesions diagnosis from MRI scans of the target knee

• All subjects must also satisfy at least 1 of the following inclusion criteria:

• Isolated knee articular cartilage lesion (single lesion) estimated to be =3 cm2 as demonstrated on MRI scanning. Multiple knee articular cartilage lesions (multiple lesions) with at least 1 lesion estimated to be =3 cm2 as demonstrated on MRI scanning. Bipolar cartilage defects demonstrated on MRI scanning with at least 1 articular surface lesion to be =3 cm2. One or more cartilage defects involving the patello-femoral joint as demonstrated on MRI scanning with at least 1 lesion =3 cm2. One or more cartilage defects involving the tibio-femoral joint as demonstrated on MRI scanning with at least 1 lesion to be =3 cm2. Previously failed cartilage repair procedures (i.e., microfracture, osteochondral autograft transplantation surgery (OATS), ACI)

Exclusion Criteria:

• Three or more previous surgical interventions on the knee in question.

• Preoperative flexion deformity greater than 10 degrees.

• Presence of ligamentous injury which would require reconstruction, varus or valgus deformity requiring osteotomy, or cases that require complex surgery prior to cartilage regeneration

Related Conditions & MeSH terms

• Articular Cartilage Disorder of Knee
• Articular Cartilage; Degeneration
• Cartilage Diseases

Intervention

Biological:
• Autologous peripheral blood stem cells and hyaluronic acid
Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy

Other:
• Hyaluronic acid
Regimen of intra-articular HA injections and postoperative physiotherapy

Locations

Country	Name	City	State
Malaysia	Kuala Lumpur Sports Medicine Centre	Kuala Lumpur
United States	Andrews Research & Education Foundation (AREF)	Gulf Breeze	Florida

Sponsors (1)

Lead Sponsor	Collaborator
KLSMC Stem Cells, Inc.

Countries where clinical trial is conducted

United States,  Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]		up to 24 months
Primary	International Knee Documentation Committee (IKDC) score	Subjective IKDC core as a measure of joint function	24 months
Primary	Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain	KOOS pain subdomain score as a measure of joint pain	24 months
Secondary	Numeric Rating Scale (NRS) for pain	Numeric Rating Scale (NRS) for pain	24 months