Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute
About this trial
This study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with bone-to-bone (BTB) patellar tendon autograft with the Principal Investigator (PI).
Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.
Disqualifiers
Under 18 years of age
Prior surgery on affected knee
Diabetes
Root repair, inflammatory arthropathy, or any other concomitant procedure that cannot follow an accelerated PT protocol or any concomitant procedure that the PI deems exclusionary
Trial design
Design model
Single group
Treatments tested in this trial
Autologous Mesenchymal Stromal Cells
Biological/VaccineAutologous mesenchymal stromal/stem cells extracted from the subject during a routine standard of care ACL reconstruction surgery and reintroduced in one clinic visit approximately 21 days after completion of the surgery. After being removed from the patient, the cells will be cultured, modified, and harvested to become the final investigational product. Each subject will receive 1.5 ml of the investigative drug. This will contain 5x10\^7 (50 million) autologous MSCs.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Intra-articular injection of autologous mesenchymal stromal cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Participants will be asked via a follow-up phone call following injection whether or not they have experienced any adverse events following the injection. They will be assessed at all remaining standard of care follow up visits and staff will inquire about adverse events.
Time frame
4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop2
Knee Function
Knee function will be assessed through patient reported responses on the Knee Injury and Osteoarthritis Outcome Score (KOOS) survey via REDCap. The Questionnaire has five subscales which are separately scored (pain, function in daily living, function in sport and recreation, other symptoms and knee-related quality of life). Final score will be determined on a scale of 0-100 where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time frame
Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop3
Knee Function
Function will be assessed with the International Knee Documentation Committee Subjective Knee Form (IKDC) which contains sections on knee symptoms, function, and sports activities. Total score will range from 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame
Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop4
Knee Function
Active and passive Range of Motion (ROM) of the operated and contralateral knee will be documented by the physician. This will be determined by the measurement of angles in each plane at the body's joints.
Time frame
Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postopSecondary outcomes
1
Knee Pain
Pain levels will be assessed using patient reported outcomes via REDCap. The Visual Analogue Scale will ask participants to mark on a line, using a ruler, how much pain they are in. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame
Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop2
Return to Sport Time
Return to sport time will be evaluated via the subject's standard of care (SOC) physical therapy notes in their chart.
Time frame
3 months postop3
Knee Swelling
The trans-patellar circumference of both knees will be measured at the standard of care (SOC) appointments the subject will attend throughout the study to monitor swelling. Knees will be measured utilizing a flexible measuring tape and the affected knee will be compared to the unaffected knee to verify the difference in size, and therefore the severity of swelling. The greater the difference in size between knees, the more severe the swelling.
Time frame
Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop4
Knee Pain
Questions related to pain will also be assessed on the International Knee Documentation Committee Subjective Knee Form (IKDC), although this is not its primary focus. Total score will range from 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame
Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postopSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov