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Cell Therapy
Fibroblast Injection for Amputee Limb Care
Phase 2
Recruiting
Research Sponsored by Major Extremity Trauma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a transtibial amputation
Ages 18 to 75, inclusive
Must not have
Known bleeding disorder.
Ulcers exceeding 4cm in diameter or 2cm in radius
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months from the injection visit
Awards & highlights
No Placebo-Only Group
Summary
This trial will test injections of volar fibroblasts to improve skin firmness for amputees. Participants will be randomly assigned to receive injections or a placebo. Monitored for 3 months.
Who is the study for?
Adults aged 18-75 with a below-the-knee amputation who use a prosthetic leg can join this trial. They must have healthy skin on the limb, not be pregnant or breastfeeding, and agree to contraception during the study. Smokers, those with certain skin diseases, active infections, bleeding disorders or taking immunosuppressants are excluded.
What is being tested?
The trial is testing injections of volar fibroblasts (cells from one's own body) into the residual limbs of amputees to see if it makes their skin firmer compared to a control group receiving a placebo. Participants will be followed for up to three months after treatment.
What are the potential side effects?
Potential side effects may include complications at injection sites such as pain or infection, allergic reactions to materials used in the procedure, and general discomfort from biopsy and tattooing required for cell harvesting and site marking.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had an amputation below the knee.
Select...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a known bleeding disorder.
Select...
I have ulcers larger than 4cm across.
Select...
I am a quadriplegic.
Select...
I have a history of blood disorders or take medications that can affect my blood.
Select...
I have dead tissue on my amputation stump or slow blood return in stump skin.
Select...
I am currently smoking or using tobacco products.
Select...
I am not on long-term immunosuppressive treatments, including oral or topical steroids.
Select...
I do not have an infection in my amputated limb.
Select...
I have an autoimmune skin condition like lupus.
Select...
I have a skin wound that is deeper than the outer layer of my skin.
Select...
My ulcers can't be treated with a wide margin of healthy tissue around them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months from the injection visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months from the injection visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of autologous volar fibroblasts for increasing skin firmness in individuals with a transtibial amputation.
Safety assessment of complications and adverse events associated with Volar Fibroblast injections
Other study objectives
Participant reported health care utilization
Participant reported medication and treatment
Participant reported physical function and activity
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Volar Fibroblast TreatmentExperimental Treatment1 Intervention
Volar fibroblasts are injected into the residual limb of transtibial amputees
Group II: CryoprotectantActive Control1 Intervention
Vehicle Control. Interdermal injection of cryoprotectant
Find a Location
Who is running the clinical trial?
Major Extremity Trauma Research ConsortiumLead Sponsor
31 Previous Clinical Trials
27,436 Total Patients Enrolled
United States Department of DefenseFED
917 Previous Clinical Trials
334,679 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin is healthy and I don't have severe skin conditions or non-healing wounds.I have a known bleeding disorder.I have ulcers larger than 4cm across.I am a quadriplegic.I am not pregnant, won't get pregnant or breastfeed during the study, and will use birth control.I have a history of blood disorders or take medications that can affect my blood.I am an amputee with painful nerve growths in my limb stump from the last 3 months.I have dead tissue on my amputation stump or slow blood return in stump skin.I am currently smoking or using tobacco products.I am not on long-term immunosuppressive treatments, including oral or topical steroids.I do not have an infection in my amputated limb.I have an autoimmune skin condition like lupus.My doctor thinks my medical history makes it unsafe for me to join the study.I have been using a prosthesis for 3 months or had one integrated into my bone for 1 month.I have a skin wound that is deeper than the outer layer of my skin.My ulcers can't be treated with a wide margin of healthy tissue around them.I have had an amputation below the knee.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Volar Fibroblast Treatment
- Group 2: Cryoprotectant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.