Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase II Safety/Efficacy Study of A Combination Stem Cell Therapy That Develops Mature Stable Vessel Formation in Ischemic Limbs
Brief Summary: The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.

Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.

LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.

In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.

The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.

Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.

Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.


Options:
A: Arm Label: Low Dose; Type: ACTIVE_COMPARATOR; Interventions: Biological: Ad2/HIF-1α/VP16 | Arm Label: Middle Dose; Type: ACTIVE_COMPARATOR; Interventions: Biological: Ad2/HIF-1α/VP16 | Arm Label: High Dose; Type: ACTIVE_COMPARATOR; Interventions: Biological: Ad2/HIF-1α/VP16 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Saline (Placebo Control) | Intervention Type: BIOLOGICAL; Name: Ad2/HIF-1α/VP16; Assigned to Arm(s): Low Dose | Intervention Type: BIOLOGICAL; Name: Ad2/HIF-1α/VP16; Assigned to Arm(s): Middle Dose | Intervention Type: BIOLOGICAL; Name: Ad2/HIF-1α/VP16; Assigned to Arm(s): High Dose | Intervention Type: OTHER; Name: Saline (Placebo Control); Assigned to Arm(s): Placebo
B: Arm Label: MESENDO; Type: EXPERIMENTAL; Interventions: Biological: MESENDO | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: MESENDO; Assigned to Arm(s): MESENDO | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): placebo
C: Arm Label: placebo; Type: EXPERIMENTAL; Interventions: Drug: placebo | Arm Label: NV1FGF 16 mg; Type: EXPERIMENTAL; Interventions: Drug: XRP0038 (NV1FGF) | Arm Label: NV1FGF 32 mg; Type: EXPERIMENTAL; Interventions: Drug: XRP0038 (NV1FGF) | Intervention Type: DRUG; Name: XRP0038 (NV1FGF); Assigned to Arm(s): NV1FGF 16 mg, NV1FGF 32 mg | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
D: Arm Label: NV1FGF 500 μg; Type: EXPERIMENTAL; Interventions: Drug: XRP0038 (NV1FGF) | Arm Label: NV1FGF 2000 μg; Type: EXPERIMENTAL; Interventions: Drug: XRP0038 (NV1FGF) | Arm Label: NV1FGF 4000 μg; Type: EXPERIMENTAL; Interventions: Drug: XRP0038 (NV1FGF) | Intervention Type: DRUG; Name: XRP0038 (NV1FGF); Assigned to Arm(s): NV1FGF 2000 μg, NV1FGF 4000 μg, NV1FGF 500 μg

Answer: B