RECRUITING

Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=10) or to vehicle control (n=10). Participants will undergo a biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the residual limb. Fibroblasts will be processed at the Hopkins Cellular Therapy Core Lab and volar cells primed for injection will be sent to participating centers for administration. Participants randomized to the treatment group will be treated with low-dose cells. Injections will be administered on at least 1 and up to three separate days over the course of one week. Participants randomized to the vehicle control group will receive injection of cryoprotectant. All participants will be followed at 2 weeks, 1, 2, and 3 months after the last injection. These visits will include a clinical evaluation for complications, non-invasive assessments of skin firmness and thickness, skin appearance, and patient-reported outcomes. After the final monitoring visit, individuals randomized to the vehicle control group will have the opportunity to receive the volar fibroblast injections and will be followed for an additional 3 months. The investigators hypothesize that (1) There will be no difference in the rate of serious adverse events among patients treated with volar fibroblast injections compared with patients treated with vehicle control, and (2) Patients treated with volar fibroblast injections will have firmer skin on the residual limb compared with patients tread with vehicle alone.

Official Title

A Phase 2 Multicenter Randomized Single Arm Crossover Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees

Quick Facts

Study Start:2022-09-26

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04839497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ages 18 to 75, inclusive 2. Must have a transtibial amputation 3. Must be using a prosthesis within the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month 4. In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained up to 14 days before baseline for which the investigator identified no clinically significant abnormality. 5. Able to provide written informed consent 6. Females of childbearing potential must: 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 be willing to use a reliable form of contraception during the study. 7. Has healthy skin on the residual limb and is free of severe and active skin disease (excluding those on the residual limb) such as extreme and active eczema or psoriasis, active non-healing wounds, lichen planus, a history of keloid scare formation or lupus as determined by the investigator or study nurse. 8. 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.	1. A skin erosion deeper than the skin dermis. 2. Ulcers exceeding 4cm in diameter or 2cm in radius 3. Non circular ulcers that cannot tolerate a 1cm margin at all sides 4. Having received any investigational drug within 30 days prior to study entry 5. An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%). 6. Pregnant, lactating, or trying to become pregnant 7. A history of keloid formation 8. Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, HTLV I/II, Hepatitis B, Hepatitis C). 9. Autoimmune diseases affecting the skin such as lupus. 10. Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds 11. Active infection of the residual limb (e.g. osteomyelitis, wound or skin condition with surrounding swelling, erythema, drainage, pain, gangrenous tissue or fever). 12. Active smoker during the study (this includes e cigarettes and any type of tobacco use) 13. We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation. 14. Amputees with symptomatic neuromas of the terminal limb within the last 3 months. 15. Known bleeding disorder. 16. Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Paraaminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.) 17. Quadriplegics

Inclusion Criteria

Exclusion Criteria

1. Ages 18 to 75, inclusive
2. Must have a transtibial amputation
3. Must be using a prosthesis within the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month
4. In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained up to 14 days before baseline for which the investigator identified no clinically significant abnormality.
5. Able to provide written informed consent
6. Females of childbearing potential must: 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 be willing to use a reliable form of contraception during the study.
7. Has healthy skin on the residual limb and is free of severe and active skin disease (excluding those on the residual limb) such as extreme and active eczema or psoriasis, active non-healing wounds, lichen planus, a history of keloid scare formation or lupus as determined by the investigator or study nurse.
8. 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.

1. A skin erosion deeper than the skin dermis.
2. Ulcers exceeding 4cm in diameter or 2cm in radius
3. Non circular ulcers that cannot tolerate a 1cm margin at all sides
4. Having received any investigational drug within 30 days prior to study entry
5. An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%).
6. Pregnant, lactating, or trying to become pregnant
7. A history of keloid formation
8. Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, HTLV I/II, Hepatitis B, Hepatitis C).
9. Autoimmune diseases affecting the skin such as lupus.
10. Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds
11. Active infection of the residual limb (e.g. osteomyelitis, wound or skin condition with surrounding swelling, erythema, drainage, pain, gangrenous tissue or fever).
12. Active smoker during the study (this includes e cigarettes and any type of tobacco use)
13. We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.
14. Amputees with symptomatic neuromas of the terminal limb within the last 3 months.
15. Known bleeding disorder.
16. Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Paraaminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.)
17. Quadriplegics

Contacts and Locations

Study Contact

Dana Alkhoury

CONTACT

410- 955-7498

dalkhou1@jhu.edu

Luis Garza, MD

CONTACT

lag@jhmi.edu

Study Locations (Sites)

Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Major Extremity Trauma Research Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-26

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2022-09-26

Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

Amputation