Mesenchymal Stem Cell Treatment for Primary Osteoarthriti... | NCT02544802

Studies
Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

NCT02544802

Sponsor

Steminent Biotherapeutics Inc.

Status

Completed

Last Update Posted

Oct 28, 2022Actual

Enrollment

4Actual

Phase

Phase 1

Conditions

Osteoarthritis Knee

Interventions

Adipose-Derived Mesenchymal Stem Cells

Countries

Taiwan

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 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

Jun 2015

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Sep 4, 2015

First Submission Date that Met QC Criteria

Sep 6, 2015

First Posted Date

Sep 9, 2015Estimated

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

Oct 26, 2022

Last Update Posted Date

Oct 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADMSCs	Experimental	Three intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection	Drug: Adipose-Derived Mesenchymal Stem Cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adipose-Derived Mesenchymal Stem Cells	Drug		ADMSCs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical assessment of visual analogue scale (VAS)		12 months
Clinical assessment of Short Form 36 questionnaire (SF-36)		12 months
Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
Subject's pain score is 8-13 points (Lequesne's index).
Ages between 50-70 years.
Signed informed consent from the subject.
Female subjects should be post-menopausal women

Exclusion Criteria:

Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
Subject not suitable for liposuction surgery.
Subject with hypersensitivity/allergy to anesthetic.
Subject's creatinine values higher than 1.6mg/dl.
Subject with body mass index, BMI over 30.
Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
Subject enrolled in any other cell therapy studies within the past 30 days.
Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases