Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

Osteoarthritis,Knee Clinical Trial

Official title:

Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007576
• Other study ID #: EMOCT01
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2019
• Source: EMO Biomedicine Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". MSCs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for osteoarthritis treatment becomes a developing target for new generation drugs.

This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. On the distribution day, cell will be thawed and injected into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion of seven days, one month, six months and one year. The monitoring items include the changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects who understand and sign the informed consent form for this study

2. Grade 2~3 osteoarthritis according to the Kellgren-Lawrence grading scale with one-month X-ray

3. Age is 50~75 years old

4. Postmenopausal women

5. VAS scores in 50 to 90 mm

Exclusion Criteria:

1. Abnormal of liver and kidney: GOT and GPT > 100 IU/L, BUN >22 mg/dl and creatinine > 1.2 mg/dl.

2. Positive serology for HIV, HTLV-1/2 and syphilis

3. Women who are pregnant or breast feeding

4. Serious pre-existing medical conditions: coagulation disorders, cardiovascular diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history.

5. Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis, serious meniscal tear, other autoimmune arthritis.

6. Skin inflammatory of knee

7. Knee pain caused by referred pain from spine disease or hip joint disease. Knee pain combined with pain from spine disease or hip disease.

8. Immunosuppressive state

9. Subjects who were injected with hyaluronic acid and PRP in the past 6 months

10. Body mass index (BMI) greater than 30

11. Have a history of allergic reaction of any medication

12. Participation in another clinical trial or treatment within 3 months

13. Other pathologic conditions or circumstances that difficult participation in this study according to PI's evaluations

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis,Knee

Intervention

Biological:
• RegStem
RegStem, 1.5 ml, one injection

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
EMO Biomedicine Corporation	Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.		48 weeks
Primary	Clinical assessment of International Knee Documentation Committee (IKDC) score	Assess symptoms of knee, sport activity and function of knee	48 weeks
Secondary	Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)		48 weeks
Secondary	Clinical assessment of visual analogue scale (VAS)		48 weeks
Secondary	Clinical assessment of knee X-ray		48 weeks
Secondary	Clinical assessment of knee MRI		48 weeks