Clinical trials: Regenerative Medicine
Heart Failure, Cardiovascular Diseases
Novel INXN-4001 Triple Effector Plasmid in Heart Failure
To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-related adverse events occurring…
- Conditions
- Heart Failure, Cardiovascular Diseases, Heart-Assist Device
- Trial name
- NCT03409627
- Testing
- INXN-4001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Triple-Gene, LLC
ARDS, Human, Covid19
Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER)
A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV…
- Trial name
- RECOVER (NCT04629105)
- Testing
- Longeveron Mesenchymal Stem Cells (LMSCs)
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Longeveron Inc.
Diabetes Mellitus, Ulcer Foot
Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People
The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern…
- Conditions
- Diabetes Mellitus, Ulcer Foot, Ulcer Healing, Diabetic Foot Ulcer
- Trial name
- NCT05251480
- Testing
- Standard of Care, DermGEN™
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- DeCell Technologies Inc.
Amyotrophic Lateral Sclerosis
GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS)
GM604 is an endogenous human embryonic stage neural regulatory and signaling peptide that controls the development, monitoring and correction of the human nervous system.
- Trial name
- GALS (NCT01854294)
- Testing
- GM604
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Genervon Biopharmaceuticals, LLC
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Chronic Kidney Disease
A Phase 1, Open-label Safety Study of NKA in Patients With Type 2 Diabetes
The purpose of this study is to determine if selected renal cells, obtained by biopsy from a patient with chronic kidney disease (CKD) and Type 2 Diabetes (i.e., autologous cells) can be safely implanted back into the patient.
- Trial name
- NCT02008851
- Testing
- Neo-kidney augment
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- Tengion
Osteoarthritis, Tendinitis
Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions
The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions.
- Conditions
- Osteoarthritis, Tendinitis, Sports Injury, Degenerative Disc Disease
- Trial name
- NCT03390920
- Testing
- Umbilical Allograft
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- R3 Stem Cell
Chronic Ischemic Stroke
CC-101 (f/k/a NR1) Neural Stem Cell Transplantation for Adults With Chronic Ischemic Stroke
The suNR1se II Study is a Phase 2b randomized, controlled, multi-center clinical trial evaluating the efficacy and safety of stereotactic intracerebral administration of CC-101 (f/k/a NR1), an investigational allogeneic neural…
- Trial name
- suNR1se II (NCT07709845)
- Testing
- CC-101 (f/k/a NR1) Intracerebral Transplantation, Tacrolimus
- Volunteers
- 36 people
- Sponsor
- Clarion Cells, Inc.
Breast Implant Revision, Congenital Breast Defect Correction
Scaffold-guided Breast Surgery
The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits.
- Trial name
- NCT05437757
- Testing
- Surgical implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Sensorineural Hearing Loss, Tinnitus
Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss
The HEAR-RESTORE study is an exploratory clinical research program designed to evaluate new diagnostic and regenerative approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss.
- Conditions
- Sensorineural Hearing Loss, Tinnitus, Acoustic Trauma, Inner Ear Injury
- Trial name
- HEAR-RESTORE (NCT07472023)
- Testing
- Audiologic Monitoring, Investigational Regenerative Pharmacologic Therapy, Stem Cell Regenerative Therapy
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Truway Health, Inc.
Malignant Melanoma With Metastasis, Malignant Melanoma
Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma
The protocol is a Simon's 2-stage, non-randomized, open label, multi-site, phase 2 trial for patients with advanced metastatic, recurrent and unresectable malignant melanoma that has recurred or relapsed after prior anti-PD-(L)1…
- Conditions
- Malignant Melanoma With Metastasis, Malignant Melanoma, Malignant Melanoma Stage IIIc, Malignant Melanoma Stage IV
- Trial name
- NCT06708455
- Testing
- RAPA-201 Rapamycin Resistant T Cells, Chemotherapy Prior to RAPA-201 Therapy
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Rapa Therapeutics LLC
Non-melanoma Skin Cancer, Basal Cell Carcinoma
EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers.
- Conditions
- Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Trial name
- NCT02409628
- Testing
- EktoTherix
- Where
- 3 sites in United Kingdom
- Volunteers
- 12 people
- Sponsor
- Neotherix Limited
Orthopedic Disorder, Neurologic Disorder
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions.
- Conditions
- Orthopedic Disorder, Neurologic Disorder, Urologic Diseases, Erectile Dysfunction
- Trial name
- NCT03899298
- Testing
- Amniotic and Umbilical Cord Tissue Procedure
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- R3 Stem Cell
Diabetic Foot, Diabetic Foot Ulcer
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Chronic Foot Ulcer
- Trial name
- NCT06035536
- Testing
- Symphony™ plus Off-loading, Wound Dressing comprising of calcium alginate Fibracol
- Where
- 11 sites in United States
- Volunteers
- 143 people
- Sponsor
- Aroa Biosurgery Limited
Diabetic Foot
SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
- Trial name
- NCT06140303
- Testing
- SkinTE, Control
- Where
- 23 sites in United States
- Volunteers
- 100 people
- Sponsor
- PolarityTE
Esophageal Diseases
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
Cellspan™ Esophageal Implant-Adult (CEI) The CEI is a combination product consisting of an engineered synthetic scaffold (device constituent) seeded and cultured with the patient's adipose derived mesenchymal stem cells (biologic…
- Trial name
- NCT05877300
- Testing
- CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus, CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Harvard Apparatus Regenerative Technology, Inc.