autologous skin fibroblasts for Wounds

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Johns Hopkins School of Medicine, Dermatology Department, Baltimore, MD
Wounds
autologous skin fibroblasts - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a skin graft from the palm of the hand can be used to treat burns.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether autologous skin fibroblasts will improve 1 primary outcome and 1 secondary outcome in patients with Wounds. Measurement will happen over the course of 6 months.

6 months
Cytoplasmic size increase
Durometer reading

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

autologous skin fibroblasts
1 of 1
Experimental Treatment

This trial requires 80 total participants across 1 different treatment group

This trial involves a single treatment. Autologous Skin Fibroblasts is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

autologous skin fibroblasts
Biological
we are comparing 3 injection sites in the same individual

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Johns Hopkins School of Medicine, Dermatology Department - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Be willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.
Be able to comprehend the informed consent document and provide consent for participation
have a negative pregnancy test at screening
agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study
May be male or female
Must be between 18 years and 65 years of age
In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality.
be willing to use a reliable form of contraception during the study
Have healthy skin as determined by the PI or study Nurse Practitioner.

Patient Q&A Section

What are common treatments for wounds?

"There are many different treatments used to treat wounds, depending on the nature of the wound and the individual's healing ability. Many wounds require a skin graft to close the wound. Some wounds may need to be covered by sutures or gauze and can require several months to heal." - Anonymous Online Contributor

Unverified Answer

How many people get wounds a year in the United States?

"In 2001, the US was experiencing a major increase in the number of amputations across racial and ethnic groups. This was disproportionately experienced in African American men. Amputation was experienced by 3.8% of US males and 0.3% of US females. There were significantly larger absolute numbers of individuals who experienced amputations for traumatic compared with nontraumatic causes in all groups." - Anonymous Online Contributor

Unverified Answer

What are the signs of wounds?

"Signs may present at different times during the healing process. For example, bruising may be a sign of excessive tearing of blood vessels in response to stress that often follows surgery. Scars may develop after surgery because of excessive tearing of blood vessels or in response to long periods of healing." - Anonymous Online Contributor

Unverified Answer

Can wounds be cured?

"There is no evidence of wound-healing property of electroacupuncture. The study provides insight into the role of wound healing in EA therapy for somatic pain, which has long been a subject of debate. Besides, we are in a position to ascertain the effects of EA on regeneration." - Anonymous Online Contributor

Unverified Answer

What is wounds?

"Wounds, commonly caused by traumatic and non-traumatic circumstances, are an important global community health issue. The current understanding of wounds is very limited. Inadequate knowledge of wounds presents a challenge to global health. Research into the epidemiology, burden and care of wounds will enable governments and policymakers to formulate effective public health policies. A global plan is urgently needed for improving wound care." - Anonymous Online Contributor

Unverified Answer

What causes wounds?

"There is evidence of a relationship between some types of infection and increased incidence of colon cancer. It may be due to a possible relationship between bacteria, diet or infections or, alternatively, there may be a common link between infections and colitis. question: What causes gingivitis? answer: It appears that the aetiology of gingivitis is multifactorial, with both genetic and environmental factors. The data also show a strong association between smoking and gingivitis. Some findings are suggestive of a link between periodontal disease and periodontal plaque and gingivitis." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for wounds?

"Clinical trials are still being conducted on a fairly regular basis. However, the overwhelming majority of the wounds currently studied in the literature have failed to demonstrate an effect when randomized comparison to placebo is applied. There is still considerable scope for improvement in clinical trial design for this topic. Power makes it convenient to explore how much a clinical trial for wound healing is affected by factors such as your wound type, type of dressing, method of dressing, timing, and so on. [Power]: http://www.withpower.com/clinical-trials/wounds is a powerful and informative platform for exploring wound healing." - Anonymous Online Contributor

Unverified Answer

What does autologous skin fibroblasts usually treat?

"Autologous skin fibroblasts of an adult age usually have a positive impact and can be a new cell therapy for all skin diseases where cells are necessary. It is worthwhile to study this treatment approach in more detail." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in autologous skin fibroblasts for therapeutic use?

"Our studies showed that the method can be used as a simple and reproducible method for the production of healthy skin cells that can be used to support the recovery process after burn injury. The cells can be produced for use as a skin substitute, as they have the properties of both fibroblastic and dermal layers." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating wounds?

"The most notable new insight is that the human skin microbiome seems to have a role in the initiation and severity of acute and chronic wounds." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets wounds?

"[Without a doubt] wounds are the most common and most common injuries, but our data also showed that they are one of the injuries which can be neglected. Results from a recent clinical trial brought up the need to revise our attitudes, by incorporating more awareness and education about wounds. This would lead us to take a more active role in patient's follow-up, and it is also needed to implement a policy-making system which is more flexible and has to be updated every three years. We also needed to rethink our attitudes towards care providers." - Anonymous Online Contributor

Unverified Answer

Does autologous skin fibroblasts improve quality of life for those with wounds?

"The use of autologous fibroblasts in a wound dressing resulted in significant gains in health-related quality of life and self-esteem. These improvements were maintained beyond the immediate 2-month period on which the dressing was used. There were also significant gains in pain and itching perception. Use of autologous skin fibroblasts is a simple method for improving quality of life after the loss of such a complex limb. It is inexpensive and readily available." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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