What side effects are associated with this type of intervention?

Common treatments for lung diseases, particularly those involving autologous adipose-derived stromal cells (like AD-cSVF), often aim to reduce inflammation and promote tissue regeneration. Known side effects of these treatments can include local reactions at the injection site, potential for infection, and immune responses. For mesenchymal stem cell (MSC) therapies, side effects may also include transient fever, headache, and in rare cases, thrombotic events. Other biologic treatments, such as those using glucocorticoids, can lead to side effects like hyperglycemia, increased risk of infection, and impaired wound healing. It is important to discuss these potential risks with a healthcare provider to weigh the benefits and drawbacks of these therapies.

What prior FDA approvals exist?

The FDA has approved several treatments for lung diseases, particularly focusing on anti-inflammatory and regenerative properties. For idiopathic pulmonary fibrosis (IPF), antifibrotic agents like nintedanib have been approved, showing efficacy in slowing disease progression. While investigational therapies such as stem cell treatments, including those similar to AD-cSVF, are being studied for their potential in lung repair and regeneration, they have not yet received FDA approval. Systemic glucocorticoids and other anti-inflammatory agents are commonly used in various lung conditions, although their use is often based on clinical judgment rather than specific FDA approval for regenerative purposes.

What other types of research exist?

Promising novel alternatives to AD-cSVF for lung disease patients include: 1) Pamrevlumab, an anti-connective tissue growth factor therapy, which has shown positive results in idiopathic pulmonary fibrosis in a phase 2 trial. 2) Mesenchymal stem cell (MSC) therapy, which has demonstrated beneficial effects in various lung diseases, including COPD and idiopathic pulmonary fibrosis, through its anti-inflammatory and regenerative properties.

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Stem Cell Therapy

Stem Cell Therapy for Lung Disease (ADcSVF-COPD Trial)

Phase 1 & 2

Waitlist Available

Led By Robert W Alexander, MD

Research Sponsored by Healeon Medical Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior Diagnosis of moderate to severe COPD

GOLD II a, III, IV

Must not have

Subjects with documented Alpha-1 Antitrypsin Deficiency (Inherited lung and liver disorder)

Unwilling or not competent to understand and execute an informed consent agreement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for COPD that involves injecting special cells from fat tissue into the bloodstream. It aims to help patients who do not get better with usual treatments by reducing lung inflammation and improving breathing.

Who is the study for?

This trial is for adults with moderate to severe COPD, a lung condition causing poor airflow and difficulty breathing. Candidates must not have hepatitis (except past Hepatitis A), drug/alcohol dependence, life expectancy under 3 months due to other illnesses, inherited Alpha-1 Antitrypsin Deficiency, or be pregnant/lactating. They shouldn't have used investigational drugs within the last month or be on chronic immunosuppressive/chemotherapy treatments.

What is being tested?

The study tests the safety and effectiveness of using one's own adipose-derived stem/stromal cells (ADcSVF) obtained via lipoaspiration in treating COPD symptoms. It involves comparing results from this new intervention against normal saline IV treatment as a control.

What are the potential side effects?

Potential side effects may include discomfort at the fat tissue extraction site from lipoaspiration, typical risks associated with intravenous procedures like bruising or infection, and unknown reactions related to ADcSVF since it's an experimental therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with moderate to severe COPD.

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My COPD is moderate to very severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have Alpha-1 Antitrypsin Deficiency.

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I am unable or unwilling to understand or sign a consent form.

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I am on long-term medication to suppress my immune system or for chemotherapy.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety - Pulmonary Function

Secondary study objectives

Change from Baseline Lung X-Ray

Change from Baseline Respiratory Rate

Change from Baseline SGOT Blood Testing

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Normal Saline IV Arm 3Experimental Treatment1 Intervention

Normal Saline IV with AD-cSVF cells

Group II: Lipoaspiration Arm 1Experimental Treatment1 Intervention

Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat

Group III: AD-cSVF Arm 2Experimental Treatment1 Intervention

Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung diseases, particularly those with anti-inflammatory and regenerative properties, include corticosteroids, immunosuppressive agents, and cell-based therapies like autologous adipose-derived stromal vascular fraction (AD-cSVF). Corticosteroids reduce inflammation by inhibiting multiple inflammatory pathways, which helps decrease lung tissue damage and improve breathing. Immunosuppressive agents, such as tacrolimus and cyclosporine, modulate the immune response to prevent further lung injury. AD-cSVF therapy involves using a patient's own adipose-derived stem cells to promote tissue repair and regeneration, potentially improving lung function and reducing inflammation. These treatments are crucial for lung disease patients as they target the underlying inflammation and tissue damage, aiming to improve overall lung function and quality of life.

Adipose-derived stromal cell therapy affects lung inflammation and tracheal responsiveness in guinea pig model of COPD.