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Stem Cell Therapy

Intervention for Osteoarthritis

Phase 2
Waitlist Available
Research Sponsored by KLSMC Stem Cells, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will compare the effects of stem cell injections to a standard treatment for repairing knee cartilage damage.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
International Knee Documentation Committee (IKDC) score
Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain
Secondary outcome measures
Numeric Rating Scale (NRS) for pain
Other outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Side effects data

From undefined Phase 3 trial • 332 Patients • NCT01240382
1%
Eye irritation
1%
Gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.1% HA
3% DE-089

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
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.
Group II: Standard treatmentActive Control1 Intervention
Subjects randomized to the standard treatment-controlled parallel group will receive intra-articular HA injections and a physiotherapy regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous peripheral blood stem cells and hyaluronic acid
2015
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

KLSMC Stem Cells, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2015. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03101163.
~13 spots leftby Apr 2025
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