Clinical trial NCT02291926: Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect
Official title: Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cartilage Diseases
Osteoarthritis
Keywords: Human Umbilical Cord Mesenchymal Stem Cell
Mesenchymal Stem Cell
Osteoarthritis
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
Collaborators: name: Fifth Affiliated Hospital of Guangzhou Medical University
First posted: 2014-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.

Detailed description: Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.

To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility criteria: Inclusion Criteria:

* Patients must consent in writing to participate in the study by signing and dating an informed consent document
* Healthy patients with no major history of illness
* Patients must have a diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
* Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
* Patients must have had more than Grade 4 (0\~10 point numeric scale) pain at least for four months
* Patient's damaged cartilage area should be in the range of 2-6cm2

Exclusion Criteria:

* Pregnant women or lactating mothers
* Patients who have received any anti-inflammatory drugs including herb-drug within 14 days
* Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment
* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection
* Impaired liver function, abnormal blood coagulation, combine other tumor or special condition
* Patients who had participated in other clinical trials within three months prior to this study

Primary outcomes:
measure: Severity of adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Magnetic resonance imaging (MRI) of the knee
timeFrame: Before and 1,3,6,12 month after treatment
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Before and 1,3,6,12 month after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital Immunotherapy center
state: Guangdong
Study officials:
affiliation: Fifth Affiliated Hospital of Guangzhou Medical University
name: Ping J Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: