Efficacy and Safety Study of Intra-Articular Injections o... | NCT03101163

Studies
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

NCT03101163

Sponsor

KLSMC Stem Cells, Inc.

Status

Completed

Last Update Posted

Aug 16, 2022Actual

Enrollment

120Estimated

Phase

Phase 2

Conditions

Articular Cartilage Disorder of Knee
Articular Cartilage; Degeneration

Interventions

Autologous peripheral blood stem cells and hyaluronic acid
Hyaluronic acid

Countries

United States
Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Jul 2022Actual

Completion Date

Jul 2022Actual

First Submitted Date

Mar 24, 2017

First Submission Date that Met QC Criteria

Apr 3, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2022

Last Update Posted Date

Aug 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Subjects randomized to the intervention group will undergo subchondral drilling surgery according to standard protocol, and will also receive a regimen of PBSC and HA intra-articular injections and postoperative physiotherapy.	Biological: Autologous peripheral blood stem cells and hyaluronic acid
Standard treatment	Active Comparator	Subjects randomized to the standard treatment-controlled parallel group will receive intra-articular HA injections and a physiotherapy regimen.	Other: Hyaluronic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous peripheral blood stem cells and hyaluronic acid	Biological	Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
International Knee Documentation Committee (IKDC) score	Subjective IKDC core as a measure of joint function	24 months
Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain	KOOS pain subdomain score as a measure of joint pain	24 months

Secondary Outcomes

Measure	Description	Time Frame
Numeric Rating Scale (NRS) for pain	Numeric Rating Scale (NRS) for pain	24 months

Other Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]		up to 24 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Andrews Research & Education Foundation (AREF)		Gulf Breeze	Florida	32561	United States
Kuala Lumpur Sports Medicine Centre

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates